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510(k) Data Aggregation

    K Number
    K972606
    Device Name
    PREGNACOL PREGNANCY TEST
    Manufacturer
    IMMUNOSTICS, INC.
    Date Cleared
    1997-08-29

    (49 days)

    Product Code
    JHJ
    Regulation Number
    862.1155
    Why did this record match?
    Product Code :

    JHJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PREGNACOL PREGNANCY TEST is a rapid direct color enhanced latex slide agglutination test for the qualitative and semiquanitative detection of elevated levels of human chorionic gonadotropin (hCG) associated with pregnancy and is to be used as an aid in the early diagnosis of pregnancy. This test is to be used in clinical and hospital laboratories and is not for Doctor office use.
    Device Description
    Not Found
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    K Number
    K921968
    Device Name
    IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST
    Manufacturer
    TECH-CO, INC.
    Date Cleared
    1996-06-28

    (1523 days)

    Product Code
    JHJ
    Regulation Number
    862.1155
    Why did this record match?
    Product Code :

    JHJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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