BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST

    K Number: K982679 · Decision Oct 7, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    45
    Applicant Total
    12
    Review Days
    68

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    Basic Information

    Device Name
    MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST
    K Number
    K982679
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5680
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectral Diagnostics, Inc.
    Date Received
    July 31, 1998
    Decision Date
    October 7, 1998
    Product Code
    DDR
    Advisory Committee
    Immunology
    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
    DDR Myoglobin, Antigen, Antiserum, Control

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    Other Clearances by Spectral Diagnostics, Inc.

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    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
    K981474 CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)
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