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

    ACID PHOSPHATASE REAGENT SET

    K Number: K915705 · Decision Feb 27, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    13
    Review Days
    90

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    Basic Information

    Device Name
    ACID PHOSPHATASE REAGENT SET
    K Number
    K915705
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tech Intl. Co.
    Date Received
    November 29, 1991
    Decision Date
    February 27, 1992
    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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