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

    SPINCHEM ACID PHOSPHATASE REAGENT

    K Number: K821674 · Decision Jun 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    42
    Review Days
    15

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    Basic Information

    Device Name
    SPINCHEM ACID PHOSPHATASE REAGENT
    K Number
    K821674
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Smithkline Diagnostics, Inc.
    Date Received
    June 7, 1982
    Decision Date
    June 22, 1982
    Product Code
    CKB
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HE
    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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