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

    ETHYL ALCOHOL ASSAY

    K Number: K923783 · Decision Jan 21, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    7
    Applicant Total
    66
    Review Days
    177

    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
    ETHYL ALCOHOL ASSAY
    K Number
    K923783
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3040
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Reagents, Inc.
    Date Received
    July 28, 1992
    Decision Date
    January 21, 1993
    Product Code
    DMT
    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
    DMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet

    Similar 510(k) Clearances

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

    SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ETHYL ALCOHOL ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    EMIT-ST SERUM ETHYL ALCOHOL 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. →