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510(k) Data Aggregation

    K Number
    K992658
    Device Name
    OSOM ULTRA STREP A TEST, MODEL 147
    Manufacturer
    WYNTEK DIAGNOSTICS, INC.
    Date Cleared
    2000-01-18

    (162 days)

    Product Code
    GTY
    Regulation Number
    866.3740
    Why did this record match?
    Applicant Name (Manufacturer) :

    WYNTEK DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSOM® Strep A Test is a color immunochromatographic assay intended for the qualitative detection of Group A streptococcal antigen directly from throat swab specimens.
    Device Description
    The OSOM® Strep A Test is a color immunochromatographic assay.
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    K Number
    K990576
    Device Name
    OSOM CARD PREGNANCY TEST, MODEL 103
    Manufacturer
    WYNTEK DIAGNOSTICS, INC.
    Date Cleared
    1999-03-09

    (14 days)

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

    WYNTEK DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSOM® Card Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin, hCG, in urine for early detection of pregnancy for home use.
    Device Description
    OSOM® Card Pregnancy Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.
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    K Number
    K990578
    Device Name
    OSOM CARD II HCG-URINE TEST, MODEL 102
    Manufacturer
    WYNTEK DIAGNOSTICS, INC.
    Date Cleared
    1999-03-09

    (14 days)

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

    WYNTEK DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSOM® Card II hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. FOR LABORATORY AND PROFESSIONAL IN VITRO USE ONLY.
    Device Description
    OSOM® Card II hCG-Urine Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line in Result Window will appear to indicate a positive result.
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    K Number
    K974159
    Device Name
    OSOM HCG-URINE TEST MODEL 101
    Manufacturer
    WYNTEK DIAGNOSTICS, INC.
    Date Cleared
    1997-12-24

    (71 days)

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

    WYNTEK DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSOM™ hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. FOR LABORATORY AND PROFESSIONAL IN VITRO USE ONLY.
    Device Description
    Wyntek's OSOM hCG- Urine Test uses color immunochromatographic stick technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.
    Ask a Question
    K Number
    K973879
    Device Name
    OSOM CARD HCG-URINE TEST
    Manufacturer
    WYNTEK DIAGNOSTICS, INC.
    Date Cleared
    1997-11-04

    (55 days)

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

    WYNTEK DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSOM™ Card hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. FOR LABORATORY AND PROFESSIONAL IN VITRO USE ONLY.
    Device Description
    OSOM Card hCG-Urine Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a red test line in Result Window will appear to indicate a positive result.
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    K Number
    K972231
    Device Name
    OSOM MONO TEST 143
    Manufacturer
    WYNTEK DIAGNOSTICS, INC.
    Date Cleared
    1997-08-26

    (71 days)

    Product Code
    KTN
    Regulation Number
    866.5640
    Why did this record match?
    Applicant Name (Manufacturer) :

    WYNTEK DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSOM™ Mono Test is intended for the qualitative determination of infectious mononucleosis heterophile antibodies in serum, plasma or whole blood as an aids in the diagnosis of infectious mononucleosis .
    Device Description
    OSOM Mono Test uses color immunochromatographic technology with bovine erythrocyte extract coated on the membrane. If the specific IM heterophile antibody is present in the sample, a visible blue test line will appear to indicate a positive result.
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    K Number
    K965184
    Device Name
    PERFECTA PREGNANCY TEST
    Manufacturer
    WYNTEK DIAGNOSTICS, INC.
    Date Cleared
    1997-02-04

    (42 days)

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

    WYNTEK DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Perfecta Pregnancy Test is a pregnancy test intended for home use.
    Device Description
    Perfecta Pregnancy Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.
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    K Number
    K965227
    Device Name
    OSOM CLASSIC HCG-URINE TEST (115)
    Manufacturer
    WYNTEK DIAGNOSTICS, INC.
    Date Cleared
    1997-02-04

    (36 days)

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

    WYNTEK DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSOM™ Classic hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
    Device Description
    OSOM Classic hCG-Urine Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.
    Ask a Question
    K Number
    K961423
    Device Name
    OSOM STREP A TEST
    Manufacturer
    WYNTEK DIAGNOSTICS, INC.
    Date Cleared
    1996-10-11

    (182 days)

    Product Code
    GTZ
    Regulation Number
    866.3740
    Why did this record match?
    Applicant Name (Manufacturer) :

    WYNTEK DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OSOM™ Strep A Test is an immunochromatographic assay for the qualitative detection of Group A Streptococcal antigen from throat swabs or confirmation of presumptive Group A Streptococcal colonies from culture.
    Device Description
    OSOM Strep A Test uses color immunochromatographic dip stick technology with antibodies coated on the membrane. If group A Streptococcus is present in the swab sample, a blue test line will appear to indicate a positive result.
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