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

    POLY STAT SERUM/URINE HCG TEST

    K Number: K030430 · Decision Apr 18, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    2
    Review Days
    67

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    Basic Information

    Device Name
    POLY STAT SERUM/URINE HCG TEST
    K Number
    K030430
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alidex, Inc.
    Date Received
    February 10, 2003
    Decision Date
    April 18, 2003
    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 Alidex, Inc.

    K Number Device Name
    K021386 POLY STAT HCG DIPSTICK TEST