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

    HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE

    K Number: K041728 · Decision Aug 11, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    14
    Review Days
    47

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    Basic Information

    Device Name
    HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
    K Number
    K041728
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Immunostics Inc.,
    Date Received
    June 25, 2004
    Decision Date
    August 11, 2004
    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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