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Leeco Diagnostics, Inc.

Also registered as Lecco Diagnostics, Inc.

United StatesFDA applicant, unverified

Devices
50

What Leeco Diagnostics, Inc. makes

Leeco Diagnostics, Inc. manufactures in vitro diagnostic (IVD) test kits for quantifying and detecting hormones and biomarkers, including human chorionic gonadotropin (HCG), luteinizing hormone (LH), ferritin, follicle-stimulating hormone (FSH), prolactin (PRL), glycated hemoglobin (HbA1c), Epstein-Barr virus (EBV), thyroid-stimulating hormone (TSH), digoxin, and estradiol (E2). Products include enzyme immunoassays (EIA), lyophilized assays, and radioimmunoassays (RIMA) for clinical and research use.

The company’s diagnostic test kits are regulated under the FDA’s Class I and Class II device classifications, with most products requiring 510(k) clearance. These devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue50

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  • Vis-Cube Hcg (Eia) Lyophilized Jpl-044 Ref K870259

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Lee-Bead Beta Lh (Eia) Ref K854838

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Leeco Ferritin-Quant Diag. Test Kit Ref K811880

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Leeco Fsh-Quant Diagnostic Kit Ref K810663

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Leeco Glyco-Hemoglobin Diag. Test Kit Ref K801289

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Leeco Prl-Quant Diagnostic Test Kit Ref K820039

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Leeco Concep-7-Bhcg (Eia) Ii (Modified) Ref K861703

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Concep-7-Bhcg Ref K880577

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Leeco Preview(R) Ebv (Eia) Ref K895765

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Beta-Tsh-Irma Ref K853977

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Leeco Dig-Quant Diag. Test Kit Ref K830785

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Leeco E2 Quant Diag. Test Kit Ref K834586

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Leeco P.A.P. Quant. Diagnostic Kit Ref K792652

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Leeco Progesterone-Quant Diagnostic Test Kit Ref K850056

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Leeco Lh-Quant Diagnostic Kit Ref K810662

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Vis-Cube Hcg (Eia) Ref K863933

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Leeco Testosterone Diagnostic Kit Ref K860003

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Diagnostic Kit, Ferritab-Fe-59 Ref K782159

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Leeco T3-Quant Diag. Kit Ref K834348

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Leeco T3% Diagnostic Kit Ref K822575

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Concep-7-B-Hcg Ref K790397

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Leeco Testo-Quant Diag. Kit Ref K813059

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Lee-Bead Prolactin (Eia) Ref K861945

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Leeco Vis-Cube Strep A (Eia) Ref K864170

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Vis-Disk Hcg (Eia) Lyophilized Jpl-044M Ref K891095

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Prl-Quant Ref K883269

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Leeco-Screen, Strep A (Eia) Ref K860947

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Radioimmunoassay For Human Thyroid Ref K813392

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Leeco T4 Quant Diagnostics Test Kit Ref K822399

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Lee-Bead Tsh(Eia) Ref K852224

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Concep-7-Bhcg (Eia) Ref K844153

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vis-Disk Hcg (Eia) Jpl-041M Ref K891096

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vis-Cube Pregnancy Home Test, Cat. # Jpl-042 Ref K863999

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Right-Day Urinary Lh (Eia) Ref K860538

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Leeco Vis-Disk Strep-A (Eia) Ref K894122

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Leeco Concep-7-Bhcg Irma Ref K850530

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Leeco T3-Ria Diagnostic Kit Ref K830808

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Leeco Testosterone Diagnostic Kit Ref K830512

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Lee-Bead Beta Fsh (Eia) Ref K854837

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Leeco Cortisol-Quant Ref K843384

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Leeco Glyco-Hemoglobin Diagnostic Kit Ref K791103

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ige-Quant Diagnostic Test Kit Ref K831208

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Leeco Concep-7-Bhcg Leiad Ii Ref K850201

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Leeco Pregnastick (Eia) Catalog #003 Ref K880069

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Right-Day Ovulation Home Test Ref K861354

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Concep-7-Bhcg Ref K792308

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Concep-7-Bhcg Ref K812156

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Leeco Testo-Quant Diagnostic Kit Ref K803001

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Leeco Concep-7-Bhcg Eia Ref K850531

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Leeco P.A.P. - Quant Diagnostic Kit Ref K810232

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-50 of 50

Frequently asked questions

How many devices does Leeco Diagnostics, Inc. have in the registry?

The registry currently lists 50 devices for Leeco Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Leeco Diagnostics, Inc.'s devices?

Among its 50 most recently registered devices, Leeco Diagnostics, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Leeco Diagnostics, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Leeco Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Leeco Diagnostics, Inc. in the registry?

The most recently registered devices listed for Leeco Diagnostics, Inc. include VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044, LEE-BEAD BETA LH (EIA), LEECO FERRITIN-QUANT DIAG. TEST KIT and LEECO FSH-QUANT DIAGNOSTIC KIT.

Generated automatically from registry data and not verified by a human reviewer.