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

    ACTIVE INTACT PTH ELISA

    K Number: K952199 · Decision Jul 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    85
    Applicant Total
    94
    Review Days
    68

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    Basic Information

    Device Name
    ACTIVE INTACT PTH ELISA
    K Number
    K952199
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1545
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diagnostic Systems Laboratories, Inc.
    Date Received
    May 10, 1995
    Decision Date
    July 17, 1995
    Product Code
    CEW
    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
    CEW Radioimmunoassay, Parathyroid Hormone

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