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

    CPK-CS

    K Number: K790357 · Decision Apr 4, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    20
    Applicant Total
    49
    Review Days
    40

    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
    CPK-CS
    K Number
    K790357
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Hoffmann-La Roche, Inc.
    Date Received
    February 23, 1979
    Decision Date
    April 4, 1979
    Product Code
    JHT
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JHT Chromatographic Separation, Cpk Isoenzymes

    Similar 510(k) Clearances

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

    SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COULTER CK-MB ISOENZYME REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DSL CK-MB (DSL #3200)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    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
    K830482 ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE
    K830462 ABUSCREEN RADIOUMMUNOASSAY--URINE
    K830479 ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE
    K823579 COBAS REAGENT FOR TOTAL PROTEIN
    Search all 49 clearances from Hoffmann-La Roche, Inc. →