BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100

    K Number: K002128 · Decision Dec 5, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    0
    Applicant Total
    94
    Review Days
    144

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    Basic Information

    Device Name
    ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
    K Number
    K002128
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1260
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diagnostic Systems Laboratories, Inc.
    Date Received
    July 14, 2000
    Decision Date
    December 5, 2000
    Product Code
    NDR
    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
    NDR Enzyme Immunoassay, Inhibin-A

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