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

    QUANTECH CK-MB ASSAY

    K Number: K984433 · Decision Nov 1, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    3
    Review Days
    322

    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
    QUANTECH CK-MB ASSAY
    K Number
    K984433
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quantech , Ltd.
    Date Received
    December 14, 1998
    Decision Date
    November 1, 1999
    Product Code
    MYT
    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
    MYT Biosensor, Immunoassay, Cpk Or Isoenzymes

    Similar 510(k) Clearances

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

    I-STAT CREATINE KINASE MB (CK-MB)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BIOCENTREX CARDIAC PANEL

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

    Other Clearances by Quantech , Ltd.

    K Number Device Name
    K012943 THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE
    K990258 QUANTECH TOTAL B-HCG ASSAY