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

    LDH ISOENZYME REAGENT

    K Number: K781125 · Decision Aug 10, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    27
    Applicant Total
    27
    Review Days
    38

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    Basic Information

    Device Name
    LDH ISOENZYME REAGENT
    K Number
    K781125
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1445
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Electrophoresis Corp. of America
    Date Received
    July 3, 1978
    Decision Date
    August 10, 1978
    Product Code
    CFE
    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
    CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes

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    Other Clearances by Electrophoresis Corp. of America

    K Number Device Name
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    K792551 ALKALINE PHOSPHATASE REAGENT
    K792553 AGAROSE BARBITAL-EDTA BUFFER
    K792574 MOPSO BUFFER
    K792550 PONCEAU S STAIN SET
    K792549 FAT RED 7B STAIN SET
    K792552 AMIDO BLACK 10B STAIN
    K791656 ENZYME STABILIZING REAGENT (ESR)
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