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

    SANDARE ALKALINE PHOSPHATASE PROCEDURE

    K Number: K844498 · Decision Dec 10, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    10
    Applicant Total
    23
    Review Days
    20

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    Basic Information

    Device Name
    SANDARE ALKALINE PHOSPHATASE PROCEDURE
    K Number
    K844498
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sandare Chemical Co., Inc.
    Date Received
    November 20, 1984
    Decision Date
    December 10, 1984
    Product Code
    CIO
    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
    CIO Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes

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