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

    ACCUTEST HCG-URINE

    K Number: K971886 · Decision Jun 11, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    3
    Review Days
    20

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    Basic Information

    Device Name
    ACCUTEST HCG-URINE
    K Number
    K971886
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Unotech Diagnostics, Inc.
    Date Received
    May 22, 1997
    Decision Date
    June 11, 1997
    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 Unotech Diagnostics, Inc.

    K Number Device Name
    K032987 ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
    K981838 ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002