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

    STAINS, COUNTERSTAINS & GEN. PURPOSE

    K Number: K792483 · Decision Dec 18, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    3
    Applicant Total
    8
    Review Days
    29

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    Basic Information

    Device Name
    STAINS, COUNTERSTAINS & GEN. PURPOSE
    K Number
    K792483
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Laboratory Products, Inc.
    Date Received
    November 19, 1979
    Decision Date
    December 18, 1979
    Product Code
    ICL
    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
    ICL Carbol Fuchsin

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    Other Clearances by Laboratory Products, Inc.

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    K803050 SPRAY, SYNTHETIC SMEAR
    K800180 VARIOUS REAGENTS FOR BLOOD CELL ANALYZER
    K792482 CHEMISTRY ANALYZER REAGENTS
    K792481 CULTURE PLATES & TUBED MEDIA