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

    ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE

    K Number: K830482 · Decision Mar 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    8
    Applicant Total
    49
    Review Days
    37

    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
    ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE
    K Number
    K830482
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Hoffmann-La Roche, Inc.
    Date Received
    February 15, 1983
    Decision Date
    March 24, 1983
    Product Code
    DJP
    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
    DJP Radioimmunoassay, Amphetamine

    Similar 510(k) Clearances

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

    PRIMIDONE EIA TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    URINE AMPHETAMINE DIRECT RIA KIT (I-125)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    REVISED DOUBLE ANTIBODY AMPHETAMINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP

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

    Other Clearances by Hoffmann-La Roche, Inc.

    K Number Device Name
    K850727 BHCG-ROCHE EIA
    K831694 RENAK
    K830481 ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE
    K830480 ABUSCREEN RADIOIMMUNOASSAY-COCAINE META
    K830461 ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE
    K830460 ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE
    K830462 ABUSCREEN RADIOUMMUNOASSAY--URINE
    K830479 ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE
    K823579 COBAS REAGENT FOR TOTAL PROTEIN
    K823578 COBAS STANDARDS FOR CALCIUM-IN-ORGANIC
    Search all 49 clearances from Hoffmann-La Roche, Inc. →