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

    CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)

    K Number: K981474 · Decision May 7, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    12
    Review Days
    13

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    Basic Information

    Device Name
    CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)
    K Number
    K981474
    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
    April 24, 1998
    Decision Date
    May 7, 1998
    Product Code
    JJY
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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    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
    K972687 CARDIAC STATUS CONTROLS/TROPONIN I
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