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

    APPRAISE-CARDIO SAMPLE COLLECTION KIT

    K Number: K993787 · Decision Apr 14, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    4
    Review Days
    157

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    Basic Information

    Device Name
    APPRAISE-CARDIO SAMPLE COLLECTION KIT
    K Number
    K993787
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osborn Group, Inc.
    Date Received
    November 9, 1999
    Decision Date
    April 14, 2000
    Product Code
    JKA
    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
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by Osborn Group, Inc.

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    K990899 HEMOCHEK-A1C SAMPLE COLLECTION KIT
    K991800 HEMOCHEK URINE COLLECTION KIT