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510(k) Data Aggregation

    K Number
    K050352
    Device Name
    IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT
    Manufacturer
    AMERITEK RESEARCH LLC
    Date Cleared
    2005-09-01

    (202 days)

    Product Code
    JTO, JIO, JIR, JMT, LJX, LNW
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    JTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FemLab is a biochemical assay intended for use as a screening test for nitrites, blood, protein, and proline-iminopeptidase in vaginal fluid samples, and also to measure vaginal fluid pH. It is indicated for use as an aid in the presumptive diagnosis of vaginitis or urethritis when used in conjunction with other laboratory tests such as Gram stain, microscopic examination, and clinical signs and symptoms. The FemLab Vaginitis Test Kit is for professional and laboratory use only.
    Device Description
    Not Found
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    K Number
    K970832
    Device Name
    PYR SWAB
    Manufacturer
    REMEL, INC.
    Date Cleared
    1997-04-24

    (48 days)

    Product Code
    JTO
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    JTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970834
    Device Name
    GRAM SWAB
    Manufacturer
    REMEL, INC.
    Date Cleared
    1997-04-17

    (41 days)

    Product Code
    JTO
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    JTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970833
    Device Name
    INDOLE SWAB
    Manufacturer
    REMEL, INC.
    Date Cleared
    1997-04-02

    (26 days)

    Product Code
    JTO
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    JTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970009
    Device Name
    LYFO(TM) DIFFERENTIAL DISK-BACITRACIN
    Manufacturer
    MICRO BIO LOGICS, INC.
    Date Cleared
    1997-02-06

    (35 days)

    Product Code
    JTO
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    JTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962966
    Device Name
    IDS RAPID CB PLUS SYSTEM
    Manufacturer
    INNOVATIVE DIAGNOSTIC SYSTEMS, INC.
    Date Cleared
    1996-10-08

    (70 days)

    Product Code
    JTO
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    JTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961191
    Device Name
    COLISCREEN
    Manufacturer
    HARDY DIAGNOSTICS
    Date Cleared
    1996-06-17

    (83 days)

    Product Code
    JTO
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    JTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960996
    Device Name
    M. CAT BUTYRATE DISK
    Manufacturer
    HARDY DIAGNOSTICS
    Date Cleared
    1996-04-18

    (37 days)

    Product Code
    JTO
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    JTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955826
    Device Name
    GIBSON ID-M. CAT.
    Manufacturer
    GIBSON LABORATORIES, INC.
    Date Cleared
    1996-02-29

    (65 days)

    Product Code
    JTO
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    JTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K954783
    Device Name
    DRYSLIDE CARTARRHALIS
    Manufacturer
    DIFCO LABORATORIES, INC.
    Date Cleared
    1996-02-06

    (112 days)

    Product Code
    JTO
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    JTO

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