BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    CARDIAC STATUS CONTROLS/TROPONIN I

    K Number: K972687 · Decision Jul 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    492
    Applicant Total
    12
    Review Days
    11

    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
    CARDIAC STATUS CONTROLS/TROPONIN I
    K Number
    K972687
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Spectral Diagnostics, Inc.
    Date Received
    July 17, 1997
    Decision Date
    July 28, 1997
    Product Code
    JJX
    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    Similar 510(k) Clearances

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

    Beta-CrossLaps CalCheck 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Elecsys CYFRA 21-1 CalCheck 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Multichem A1c

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Audit MicroControls Linearity DROP LQ Blood Glucose

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIAISON CMV IgM Serum Control Set

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIAISON EBV IgM Serum Control Set

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Spectral Diagnostics, Inc.

    K Number Device Name
    K052519 SPECTRAL WEST NILE VIRUS IGM STATUS TEST
    DEN030002 ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
    K030057 SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST
    K022409 SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST
    K020950 SPECTRAL'S 2 IN 1 (TNI-MYO)
    K014105 SPECTRAL'S TROPONIN I
    K992127 CARDIOQUANT TROPONIN I TEST
    K991447 CARDIOQUANT CARDIAC ASSESSMENT CONTROLS
    K982679 MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST
    K981474 CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)
    Search all 12 clearances from Spectral Diagnostics, Inc. →