LogoFDA 510(k) Search
Search Filters

Search Results

Found 8 results

510(k) Data Aggregation

    K Number
    K013711
    Device Name
    BACTI-SWAB DRY
    Manufacturer
    REMEL CO.
    Date Cleared
    2001-11-26

    (19 days)

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

    REMEL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    REMEL's Bacti-Swab™ Dry collection and transport system is comprised of a sterile, rayon-tipped plastic shaft swab in a plastic sleeve for use in collection and transportation of a variety of samples to the laboratory for microbiological examination when dry swab collection is appropriate.
    Device Description
    comprised of a sterile, rayon-tipped plastic shaft swab in a plastic sleeve
    Ask a Question
    K Number
    K965149
    Device Name
    A.C.T. I
    Manufacturer
    REMEL CO.
    Date Cleared
    1997-01-22

    (30 days)

    Product Code
    JSM
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K965150
    Device Name
    A.C.T. IV
    Manufacturer
    REMEL CO.
    Date Cleared
    1997-01-22

    (30 days)

    Product Code
    JSM
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K965151
    Device Name
    A.C.T. III
    Manufacturer
    REMEL CO.
    Date Cleared
    1997-01-22

    (30 days)

    Product Code
    JSM
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K965152
    Device Name
    A.C.T. II
    Manufacturer
    REMEL CO.
    Date Cleared
    1997-01-22

    (30 days)

    Product Code
    JSM
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960090
    Device Name
    CALCOFLUOR WHITE STAIN KIT
    Manufacturer
    REMEL CO.
    Date Cleared
    1996-03-19

    (68 days)

    Product Code
    JTS
    Regulation Number
    864.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960095
    Device Name
    BACTIDROP CALCOFLUOR WHITE
    Manufacturer
    REMEL CO.
    Date Cleared
    1996-03-19

    (68 days)

    Product Code
    JTS
    Regulation Number
    864.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K955669
    Device Name
    REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK
    Manufacturer
    REMEL CO.
    Date Cleared
    1996-02-23

    (72 days)

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

    REMEL CO.

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

    Page 1 of 1