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510(k) Data Aggregation

    K Number
    K972359
    Device Name
    REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN
    Manufacturer
    REMEL, L.P.
    Date Cleared
    1997-08-28

    (64 days)

    Product Code
    JSO
    Regulation Number
    866.1700
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    REMEL's Bile Esculin Azide Agar w/ 6 μg/ml Vancomycin is a plated medium recommended for use in qualitative procedures as a selective and differential medium for the primary isolation of vancomycin resistant enterococci from surveillance cultures. This product is not intended for use as method of antimicrobial susceptibility testing. Confirmation of vancomycin resistance by an approved method is recommended as some organisms on initial isolation may overoome the inhibitory effects of the medium.
    Device Description
    Not Found
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    K Number
    K964315
    Device Name
    REMEL STAPH LATEX KIT
    Manufacturer
    REMEL, L.P.
    Date Cleared
    1997-02-07

    (101 days)

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

    REMEL, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K964421
    Device Name
    REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK
    Manufacturer
    REMEL, L.P.
    Date Cleared
    1996-12-06

    (66 days)

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

    REMEL, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961046
    Device Name
    10B ARGININE BROTH
    Manufacturer
    REMEL, L.P.
    Date Cleared
    1996-09-18

    (187 days)

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

    REMEL, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955143
    Device Name
    RPR LIQUID CONTROLS
    Manufacturer
    REMEL, L.P.
    Date Cleared
    1996-07-30

    (260 days)

    Product Code
    GMP
    Regulation Number
    866.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended use of the product
    Device Description
    Not Found
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    K Number
    K955136
    Device Name
    RPR CARD TEST KIT
    Manufacturer
    REMEL, L.P.
    Date Cleared
    1996-07-29

    (259 days)

    Product Code
    GMQ
    Regulation Number
    866.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended use of the product
    Device Description
    Not Found
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    K Number
    K961818
    Device Name
    GENTAMICIN DISK (120MCG)
    Manufacturer
    REMEL, L.P.
    Date Cleared
    1996-07-10

    (61 days)

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

    REMEL, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961819
    Device Name
    STREPTOMYCIN DISK (300MCG)
    Manufacturer
    REMEL, L.P.
    Date Cleared
    1996-07-10

    (61 days)

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

    REMEL, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960313
    Device Name
    MUELLER HINTON AGAR WITH 2% NACI
    Manufacturer
    REMEL, L.P.
    Date Cleared
    1996-03-25

    (63 days)

    Product Code
    JTZ
    Regulation Number
    866.1700
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K954986
    Device Name
    GC BASE W/ 1% GCHI
    Manufacturer
    REMEL, L.P.
    Date Cleared
    1996-02-16

    (108 days)

    Product Code
    JTY
    Regulation Number
    866.2410
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL, L.P.

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