BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

    K Number: K971716 · Decision Jun 27, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    24
    Applicant Total
    96
    Review Days
    49

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
    K Number
    K971716
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bayer Corp.
    Date Received
    May 9, 1997
    Decision Date
    June 27, 1997
    Product Code
    LAR
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LAR Enzyme Immunoassay, Procainamide

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LAR), ordered by most recent decision date.

    ONLINE TDM PROCAINAMIDE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CEDIA N-ACETYLPROCAINAMIDE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CEDIA PROCAINAMIDE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PROCAINAMIDE ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology
    View all

    Other Clearances by Bayer Corp.

    K Number Device Name
    K024062 ASCENSIA BREEZE BLOOD GLUCOSE METER
    K023944 BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
    K024017 BAYER ADVIA CENTAUR HER-2/NEU ASSAY
    K024234 ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
    K022288 COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
    K023584 ASCENSIA DEX 2 DIABETES CARE SYSTEM
    K020828 CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
    K021428 CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
    K020806 ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
    K013568 CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
    Search all 96 clearances from Bayer Corp. →