BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG

    K Number: K974009 · Decision Mar 13, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    8
    Review Days
    143

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    Basic Information

    Device Name
    PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG
    K Number
    K974009
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    International Newtech Development, Inc.
    Date Received
    October 21, 1997
    Decision Date
    March 13, 1998
    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 International Newtech Development, Inc.

    K Number Device Name
    K993850 URINALYSIS REAGENT STRIPS (10 PARAMETERS)
    K974060 MINISTRIP/ SERUM AND URINE COMBO HCG TEST
    K974059 ONE STEP MIDSTREAM HCG PREGNANCY TEST
    K970176 HCG CONTROLS
    K963132 MINI STRIP/SERUM HCG
    K963133 PS-UNIT CASSETTE/SERUM HCG
    K951705 MINISTRIP HCG