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

    DSL ACTIVE I-HCG ELISA

    K Number: K961911 · Decision Jun 28, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    94
    Review Days
    42

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    Basic Information

    Device Name
    DSL ACTIVE I-HCG ELISA
    K Number
    K961911
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diagnostic Systems Laboratories, Inc.
    Date Received
    May 17, 1996
    Decision Date
    June 28, 1996
    Product Code
    JHI
    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
    JHI Visual, Pregnancy Hcg, Prescription Use

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    Other Clearances by Diagnostic Systems Laboratories, Inc.

    K Number Device Name
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    K002128 ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
    K001086 FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
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    K981871 C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100
    K973243 ACTIVE PSA ELISA (DSL-10-9700)
    K973244 ACTIVE PSA IRMA (DSL-9700)
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