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510(k) Data Aggregation

    K Number
    K032987
    Device Name
    ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
    Manufacturer
    UNOTECH DIAGNOSTICS, INC.
    Date Cleared
    2003-11-17

    (54 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNOTECH DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Unotech Accutest hCG-Combo is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy. The intended use of the Unotech Accustrip hCG-Combo is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy.
    Device Description
    Not Found
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    K Number
    K981838
    Device Name
    ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002
    Manufacturer
    UNOTECH DIAGNOSTICS, INC.
    Date Cleared
    1998-06-25

    (30 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNOTECH DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Unotech AccuStrip hCG-Urine is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy. We intend to market this product to physicians' office laboratories and clinical laboratories in the U.S.A. as well as in the foreign countries.
    Device Description
    Not Found
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    K Number
    K971886
    Device Name
    ACCUTEST HCG-URINE
    Manufacturer
    UNOTECH DIAGNOSTICS, INC.
    Date Cleared
    1997-06-11

    (20 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNOTECH DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Unotech AccuTest hCG-Urine is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy. We intend to market this product to physicians' offices laboratories and clinical laboratories in the U.S.A. as well as in the foreign countries.
    Device Description
    Not Found
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