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

    I-STAT CREATINE KINASE MB (CK-MB)

    K Number: K051433 · Decision Dec 15, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    7
    Review Days
    197

    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
    I-STAT CREATINE KINASE MB (CK-MB)
    K Number
    K051433
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I-Stat Corporation
    Date Received
    June 1, 2005
    Decision Date
    December 15, 2005
    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.

    BIOCENTREX CARDIAC PANEL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    QUANTECH CK-MB ASSAY

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

    Other Clearances by I-Stat Corporation

    K Number Device Name
    K053597 I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
    K053110 Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge
    K031873 I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET
    K023582 I-STAT KAOLIN ACT TEST
    K031739 I-STAT CARDIAC TROPONIN (CTNI) TEST
    K020355 I-STAT PROTHROMBIN TIME TEST