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

    HCG ACCU-STICK

    K Number: K831604 · Decision Jul 19, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    5
    Review Days
    62

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    Basic Information

    Device Name
    HCG ACCU-STICK
    K Number
    K831604
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Btc Diagnostics, Inc.
    Date Received
    May 18, 1983
    Decision Date
    July 19, 1983
    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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