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

    ACID PHOSPHATASE REAGENT SET

    K Number: K821526 · Decision Jun 10, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    26
    Review Days
    20

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    Basic Information

    Device Name
    ACID PHOSPHATASE REAGENT SET
    K Number
    K821526
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Anco Medical Reagents & Assoc.
    Date Received
    May 21, 1982
    Decision Date
    June 10, 1982
    Product Code
    CKE
    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
    CKE Acid Phosphatase, Thymolphthale Inmonophosphate

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