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

    ABUSCREEN RADIOUMMUNOASSAY--URINE

    K Number: K830462 · Decision Mar 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    11
    Applicant Total
    49
    Review Days
    37

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    Basic Information

    Device Name
    ABUSCREEN RADIOUMMUNOASSAY--URINE
    K Number
    K830462
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3640
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Hoffmann-La Roche, Inc.
    Date Received
    February 15, 1983
    Decision Date
    March 24, 1983
    Product Code
    DOE
    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
    DOE Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.

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    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
    K830482 ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE
    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. →