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

    OSOM HCG COMBO TEST

    K Number: K043385 · Decision Apr 12, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    5
    Review Days
    124

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    Basic Information

    Device Name
    OSOM HCG COMBO TEST
    K Number
    K043385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genzyme Diagnostics
    Date Received
    December 9, 2004
    Decision Date
    April 12, 2005
    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 Genzyme Diagnostics

    K Number Device Name
    K983399 GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY
    K963425 GENZYME DIAGNOSTICS CONTRAST MONO
    K964156 CONTRAST STRIP HCG
    K964155 CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST