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Boehringer Mannheim Corp.

United StatesFDA applicant, unverified

Devices
343

What Boehringer Mannheim Corp. makes

The company manufactures diagnostic reagents, control materials, and assay systems for clinical laboratories, including liquid bilirubin reagents, cholesterol controls, and glycero-based calibration standards. It also produces point-of-care testing devices such as lancets for blood glucose monitoring and coagulation analyzers, alongside immunoassay kits for drug and protein detection (e.g., phenytoin, troponin T). Centrifuges for sample processing and blood urea nitrogen (BUN) test strips are also part of its portfolio.

The portfolio includes devices classified as Class I, Class II, and unclassified (U) under FDA regulations, with many products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database, and the company operates from the United States.

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

Catalogue343

Newest first, rows 201-250 of 343

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  • Triglycerides Gpo Without Free Glycerol Ref K873049

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

  • Cedia Procainamide Assay Ref K962099

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

  • Frontline Cannabis Ref K954497

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

  • Accu-Chek A1C Hemoglobin Test Ref K974491

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

  • Lytetek System Ref K770774

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

  • Accu-Chek Advantage Blood Glucose System Ref K930979

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

  • Cedia Red Blood Cell Folate (No Boil Reagent Pack) Ref K960800

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

  • Pregnancy Test Kit, Daisy 2 In Home Ref K790002

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

  • Enzymun Test R Hcg Ref K896901

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

  • Elecsys Hcg Assay Ref K961487

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

  • Accudata Glucose Test Station Ref K924475

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

  • Precinorm(R) Protein Ref K871027

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

  • Enzymun Test(R) Prolactin Ref K900695

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

  • Hct Centrifuge Ref K822445

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

  • Coaguchek System Ref K952625

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

  • Hitachi 705 Automatic Blood Chemistry Ref K811194

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

  • Tina-Quant(R) (A) C4 Ref K870931

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

  • Uric Acid Pap Ref K873363

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

  • Boehringer Mannheim Iga Assay Ref K955907

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

  • Spirometer Isolation Valve #8890 Ref K833088

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

  • Bm Precipath(R) Hdl/Ldl-C Control Ref K974826

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

  • Single Vial 10 Sgpt-Tris Ref K780636

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

  • Elecsys Calcheck Estradiol Ref K970148

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

  • Elecsys Ferritin Ref K971833

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

  • Elecsys Calcheck FT4 Ref K963164

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

  • Cedia Dau Opiate 2K Assay Ref K962795

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

  • Boehringer Mannheim/Hitachi 747 Chemistry Analyzer Ref K901003

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

  • Stattek-Glucose Low Level Ref K781075

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

  • Reflotron Potassium Test Tabs Ref K904033

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

  • Ise/Ci- Ref K912647

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

  • Boehringer Mannheim Cardiac T Troponin T Rapid Assay Ref K952478

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

  • Pyridoxal-5-Phosphate Tablets Ref K874835

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

  • Ise/Na+ Ref K912648

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

  • Elecsys Callcheck Digoxin Ref K973973

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

  • Diagnostics Alkaline Phosphatase Optimi Ref K823213

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

  • Hitachi 705 Calibrator Ref K811921

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

  • Elecsys Calcheck Tsh Ref K963147

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

  • Iron Ref K854298

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

  • Elecys Ige Assay Ref K984326

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

  • Elecsys Digoxin Ref K973112

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

  • Cedia Digoxin Ii Ref K970883

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

  • Enzymun-Test FT3 Ref K962760

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

  • Enzymun Test(R) Cortisol Ref K900485

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

  • Cedia T4 Ref K915194

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

  • Single Vial 10 Sgot-Tris Ref K780634

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

  • Tina-Quant(R) Igg Ref K862764

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

  • Reflotron Creatine Kinase Test Tabs Ref K904102

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

  • Enzymun-Test Psa Ref K965085

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

  • Ria Phase T4 Ref K800203

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

  • Cardiac T Elisa Troponin-T Ref K924392

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

Rows 201-250 of 343

Showing 201-250 of 343