BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GENERAL PROCEDURE AGAROSE FILM

    K Number: K802396 · Decision Nov 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    33
    Applicant Total
    27
    Review Days
    55

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    Basic Information

    Device Name
    GENERAL PROCEDURE AGAROSE FILM
    K Number
    K802396
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2485
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Electrophoresis Corp. of America
    Date Received
    October 2, 1980
    Decision Date
    November 26, 1980
    Product Code
    JJN
    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
    JJN Apparatus, Electrophoresis, For Clinical Use

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    Other Clearances by Electrophoresis Corp. of America

    K Number Device Name
    K792548 ALKALINE PHOSPHATASE MARKER
    K792547 AGAROSE BARBITAL BUFFER
    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)
    K791655 CPK ISOENZYME REAGENT
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