BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN

    K Number: K972359 · Decision Aug 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    39
    Applicant Total
    10
    Review Days
    64

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    Basic Information

    Device Name
    REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN
    K Number
    K972359
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Remel, L.P.
    Date Received
    June 25, 1997
    Decision Date
    August 28, 1997
    Product Code
    JSO
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

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    Other Clearances by Remel, L.P.

    K Number Device Name
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    K955143 RPR LIQUID CONTROLS
    K955136 RPR CARD TEST KIT
    K961818 GENTAMICIN DISK (120MCG)
    K961819 STREPTOMYCIN DISK (300MCG)
    K960313 MUELLER HINTON AGAR WITH 2% NACI
    K954986 GC BASE W/ 1% GCHI