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Streck Laboratories, Inc.

United StatesFDA applicant, unverified

Devices
70

What Streck Laboratories, Inc. makes

Streck Laboratories, Inc. manufactures diagnostic control materials and calibration devices for hematology analyzers, including platelet and reticulocyte controls (e.g., PARA 12 PLUS, RETIC CHEX LINEARITY), human platelet calibrators (PLATELET-CHEX-HUMAN), and differential controls (PARA 5 DIFF). Their portfolio also includes chemistry controls (CHEM-CHEX STAT), CD4/CD3/CD8 calibration and control products (CD-CHEX, CD-CHEX CD4 LOW), and hematology calibration standards (PC-CALIBRATOR). Additional offerings cover linearity verification (PARA 12 PLUS RETICS) and general hematology controls (HEMATO-CHEX).

These products are regulated under the FDA’s 510(k) pathway, with device classifications ranging from Class I to Class II. The company’s controls and calibrators are listed in the FDA’s 510(k) registry, ensuring compliance with U.S. medical device regulations. Streck Laboratories, Inc. is headquartered in the United States.

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

Catalogue70

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  • Para 12 Plus Ref K901875

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

  • Para 12 Plus Retics Ref K000945

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

  • Retic Chex Linearity Ref K000115

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

  • Platelet-Chex-Human Ref K770020

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

  • Cal-Chex Cd Plus Ref K020469

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

  • Chem-Chex Stat Ref K961195

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

  • Para 4 Plus Ref K933844

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

  • Cd-Chex Ref K920997

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

  • Pc-Calibrator Ref K781133

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

  • Para 5 Diff Ref K935196

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

  • Hemato-Chex Ref K800361

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

  • Cd-Chex CD4 Low Ref K931825

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

  • Para Tech Plus Retics Ref K993825 Open recall

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

  • Chem-Chex Ref K900993

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

  • Chem-Chex Lipid Ref K905389

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

  • A1C-Cellular Ref K040025

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

  • Para Lasar Ref K831094

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

  • Para-Tek Ref K841531

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

  • Modification To Para 5X Ref K021922

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

  • Calibration Verification Assessment (Cva) Ref K960557

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

  • Sugar-Chex Ii Ref K851043

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

  • Retic-Chex Ref K843093

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

  • Chem-Chex-Alt Ref K903147

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

  • Cyto-Chex Bct Ref K040107

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

  • Pat Platelet Aggregation Test Ref K881829

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

  • Retic-Chex For Cell-Dyn Ref K042587

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

  • Para 4 Ref K842017

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

  • Sickle-Chex Solubility Kit Ref K023656

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

  • Pipet Calibration Kit Ref K800062

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

  • Chem-Chex Stat (New) Ref K982290

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

  • Platelet-Chex Plus Ref K791226

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

  • Qc-Chex Ref K923971

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

  • Para Tech For Technicon H-1 Ref K896154

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

  • Sickle-Chex Ref K852107

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

  • Para-7 Ref K791227

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

  • Se-Check Ref K940181

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

  • Sugar Chex Linearity For The One Touch Ref K925479

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

  • Stak-Chex Plus Retics Ref K992887

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

  • Cal-Chex, A Hematology Calibrator Ref K840261 Open recall

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

  • Tekni-Cal Ref K781601

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

  • Ne-Check Ref K890767

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

  • Scs-1000 (Sysmex Calibrator System) Ref K943268

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

  • Xe Check Ref K994388

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

  • Platelet-Chex For Blood Centers Ref K792467

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

  • Chem-Chem Multi-Analyte (Modified) Ref K920350

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

  • Cell-Chex Ref K780140

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

  • Cell-Chex Ref K000076

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

  • Tnt Troponin T Ref K942632

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

  • Sickle-Chex Ref K013316

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

  • Para 5X Ref K011410

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

Rows 1-50 of 70

Showing 1-50 of 70

Frequently asked questions

How many devices does Streck Laboratories, Inc. have in the registry?

The registry currently lists 70 devices for Streck Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Streck Laboratories, Inc.'s devices?

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

What risk classes do Streck Laboratories, Inc.'s devices fall under?

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

What are the newest devices from Streck Laboratories, Inc. in the registry?

The most recently registered devices listed for Streck Laboratories, Inc. include PARA 12 PLUS, PARA 12 PLUS RETICS, RETIC CHEX LINEARITY and PLATELET-CHEX-HUMAN.

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