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

    PROCAINAMIDE ENZYME IMMUNOASSAY

    K Number: K962463 · Decision Aug 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    24
    Applicant Total
    66
    Review Days
    50

    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 ENZYME IMMUNOASSAY
    K Number
    K962463
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Reagents, Inc.
    Date Received
    June 25, 1996
    Decision Date
    August 14, 1996
    Product Code
    LAR
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    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

    PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

    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
    View all

    Other Clearances by Diagnostic Reagents, Inc.

    K Number Device Name
    K983268 MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY
    K983812 NAPA EIA ASSAY
    K983323 DIGOXIN IMMUNOASSAY
    K983280 VANCOMYCIN EIA ASSAY
    K983159 DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS
    K973102 LIDOCAINE EIA ASSAY
    K972835 50NG/ML COCAINE METABOLITE CALIBRATOR
    K972526 METHADONE EIA ASSAY
    K964212 QUINIDINE ENZYME IMMUNOASSAY
    K963835 DIGOXIN ENZYME IMMUNOASSAY
    Search all 66 clearances from Diagnostic Reagents, Inc. →