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

    ACID PHOSPHATASE (ACP) REAGENT

    K Number: K863851 · Decision Oct 16, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    164
    Review Days
    14

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    Basic Information

    Device Name
    ACID PHOSPHATASE (ACP) REAGENT
    K Number
    K863851
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sigma Diagnostics, Inc.
    Date Received
    October 2, 1986
    Decision Date
    October 16, 1986
    Product Code
    CKB
    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
    CKB Acid Phosphatase, Naphthyl Phosphate

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