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

    QUANTECH MYOGLOBIN ASSAY

    K Number: K981536 · Decision Jun 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    61

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    Basic Information

    Device Name
    QUANTECH MYOGLOBIN ASSAY
    K Number
    K981536
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5680
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hellen Professional Services
    Date Received
    April 29, 1998
    Decision Date
    June 29, 1998
    Product Code
    MVE
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MVE Biosensor, Immunoassay, Myoglobin

    Other Clearances by Hellen Professional Services

    K Number Device Name
    K020226 XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03