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

    ABUSCREEN RIA FOR PHENCYCLIDINE

    K Number: K790655 · Decision Jun 15, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    10
    Applicant Total
    49
    Review Days
    71

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    Basic Information

    Device Name
    ABUSCREEN RIA FOR PHENCYCLIDINE
    K Number
    K790655
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Hoffmann-La Roche, Inc.
    Date Received
    April 5, 1979
    Decision Date
    June 15, 1979
    Product Code
    LCL
    Advisory Committee
    Unknown
    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
    LCL Radioimmunoassay, Phencyclidine

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    K830461 ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE
    K830460 ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE
    K830482 ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE
    K830462 ABUSCREEN RADIOUMMUNOASSAY--URINE
    K830479 ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE
    K823579 COBAS REAGENT FOR TOTAL PROTEIN
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