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

    ACS CKMB II IMMUNOASSAY

    K Number: K962126 · Decision Jun 21, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    125
    Review Days
    18

    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
    ACS CKMB II IMMUNOASSAY
    K Number
    K962126
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ciba Corning Diagnostics Corp.
    Date Received
    June 3, 1996
    Decision Date
    June 21, 1996
    Product Code
    JHS
    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
    JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes

    Similar 510(k) Clearances

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

    Creatine Kinase

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CKMB UDR ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    S40 CREATINE KINASE (CK)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CARESIDE CK

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CARESIDE CKMB

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

    Other Clearances by Ciba Corning Diagnostics Corp.

    K Number Device Name
    K962559 ACS CORTISOL IMMUNOASSAY
    K963251 CIBA CORNING ACS;180 DPD ASSAY
    K961807 CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4
    K961657 CIBA CORNING 400 SYSTEM
    K962021 CIBA CORNING 348 SYSTEM
    K962041 ACS LH2 IMMUNOASSAY
    K961510 ACS FRT4 IMMUNOASSAY
    K960246 LIQUID CARDIAC MARKER 1,2,3 ASSAYED
    K955873 ACS PHENYTOIN ASSAY
    K954697 CIBA CORNING ACS ESTRADIOL-6 ASSAY
    Search all 125 clearances from Ciba Corning Diagnostics Corp. →