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

    ACID PHOSPHATASE TEST

    K Number: K873726 · Decision Jan 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    41
    Review Days
    134

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    Basic Information

    Device Name
    ACID PHOSPHATASE TEST
    K Number
    K873726
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    King Diagnostics, Inc.
    Date Received
    September 15, 1987
    Decision Date
    January 27, 1988
    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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