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

    AMIDO BLACK 10B STAIN

    K Number: K792552 · Decision Dec 18, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    27
    Review Days
    8

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    Basic Information

    Device Name
    AMIDO BLACK 10B STAIN
    K Number
    K792552
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Electrophoresis Corp. of America
    Date Received
    December 10, 1979
    Decision Date
    December 18, 1979
    Product Code
    HZZ
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HZZ Sudan Black B

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    SIGMA SUDAN BLACK REAGENT 380-1

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    Other Clearances by Electrophoresis Corp. of America

    K Number Device Name
    K802396 GENERAL PROCEDURE AGAROSE FILM
    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
    K791656 ENZYME STABILIZING REAGENT (ESR)
    K791655 CPK ISOENZYME REAGENT
    Search all 27 clearances from Electrophoresis Corp. of America →