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

    NAPA EIA ASSAY

    K Number: K983812 · Decision Nov 16, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    20
    Applicant Total
    66
    Review Days
    19

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    Basic Information

    Device Name
    NAPA EIA ASSAY
    K Number
    K983812
    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
    October 28, 1998
    Decision Date
    November 16, 1998
    Product Code
    LAN
    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
    LAN Enzyme Immunoassay, N-Acetylprocainamide

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    Other Clearances by Diagnostic Reagents, Inc.

    K Number Device Name
    K983268 MODIFICATION OF TRICYCLIC SERUM TOX 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
    K962463 PROCAINAMIDE ENZYME IMMUNOASSAY
    Search all 66 clearances from Diagnostic Reagents, Inc. →