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

    HIM TEST COCAINE

    K Number: K792429 · Decision Dec 7, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    9

    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
    HIM TEST COCAINE
    K Number
    K792429
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Tecknam, Inc.
    Date Received
    November 28, 1979
    Decision Date
    December 7, 1979
    Product Code
    DLN
    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
    DLN Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)

    Similar 510(k) Clearances

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

    URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ABUSCREEN ONLINE FOR COCAINE METABOLITE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    COCAINE KIT, TOXI-PAK

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