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

    CARESIDE LDH

    K Number: K020484 · Decision Jul 3, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    22
    Review Days
    140

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    Basic Information

    Device Name
    CARESIDE LDH
    K Number
    K020484
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1440
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Careside, Inc.
    Date Received
    February 13, 2002
    Decision Date
    July 3, 2002
    Product Code
    CFH
    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
    CFH Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase

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    Other Clearances by Careside, Inc.

    K Number Device Name
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    K020488 CARESIDE TRGLYCERIDE
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    K001462 CARESIDE HEMOGLOBIN
    K993771 CARESIDE DIRECT BILIRUBIN
    K993634 CARESIDE ANALYZER
    K992475 CARESIDE CO2, TOTAL
    K991717 CARESIDE MG
    K991371 CARESIDE AMMONIA
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