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510(k) Data Aggregation

    K Number
    K971120
    Device Name
    DISPENS-O-DISC (TM) LEVOFLOXACIN
    Manufacturer
    DIFCO LABORATORIES, INC.
    Date Cleared
    1997-04-14

    (18 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIFCO LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K971211
    Device Name
    DISPENS-O-DISC SPARFLOXACIN
    Manufacturer
    DIFCO LABORATORIES, INC.
    Date Cleared
    1997-04-14

    (18 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIFCO LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963508
    Device Name
    DISPENS-O-DISC MEROPENEM
    Manufacturer
    DIFCO LABORATORIES, INC.
    Date Cleared
    1996-09-26

    (23 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIFCO LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K961148
    Device Name
    CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)
    Manufacturer
    DIFCO LABORATORIES, INC.
    Date Cleared
    1996-04-26

    (36 days)

    Product Code
    JTW
    Regulation Number
    866.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIFCO LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    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?
    Applicant Name (Manufacturer) :

    DIFCO LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K954784
    Device Name
    DRYSIDE NEISSERIA
    Manufacturer
    DIFCO LABORATORIES, INC.
    Date Cleared
    1996-01-30

    (105 days)

    Product Code
    LTS
    Regulation Number
    866.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIFCO LABORATORIES, INC.

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

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