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

    ONE STEP MIDSTREAM HCG PREGNANCY TEST

    K Number: K974059 · Decision Apr 9, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    8
    Review Days
    164

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    Basic Information

    Device Name
    ONE STEP MIDSTREAM HCG PREGNANCY TEST
    K Number
    K974059
    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 27, 1997
    Decision Date
    April 9, 1998
    Product Code
    LCX
    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
    LCX Kit, Test, Pregnancy, Hcg, Over The Counter

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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
    K974009 PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG
    K970176 HCG CONTROLS
    K963132 MINI STRIP/SERUM HCG
    K963133 PS-UNIT CASSETTE/SERUM HCG
    K951705 MINISTRIP HCG