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

    OSOM CARD HCG-URINE TEST

    K Number: K973879 · Decision Nov 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    12
    Review Days
    55

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    OSOM CARD HCG-URINE TEST
    K Number
    K973879
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wyntek Diagnostics, Inc.
    Date Received
    September 10, 1997
    Decision Date
    November 4, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JHI), ordered by most recent decision date.

    Innovita HCG Pregnancy Rapid Combo Test

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Alltest Pregnancy Rapid Combo Test Cassette

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Atellica IM Total hCG (ThCG)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    WUNDER PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Wyntek Diagnostics, Inc.

    K Number Device Name
    K992658 OSOM ULTRA STREP A TEST, MODEL 147
    K990578 OSOM CARD II HCG-URINE TEST, MODEL 102
    K990576 OSOM CARD PREGNANCY TEST, MODEL 103
    K974159 OSOM HCG-URINE TEST MODEL 101
    K972231 OSOM MONO TEST 143
    K965227 OSOM CLASSIC HCG-URINE TEST (115)
    K965184 PERFECTA PREGNANCY TEST
    K961423 OSOM STREP A TEST
    K955141 OSOM HCG COMBO TEST
    K954178 OSOM PREGNANCY TEST
    Search all 12 clearances from Wyntek Diagnostics, Inc. →