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

    MRSASELECT

    K Number: K070361 · Decision Sep 13, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    39
    Applicant Total
    319
    Review Days
    218

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    Basic Information

    Device Name
    MRSASELECT
    K Number
    K070361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Rad
    Date Received
    February 7, 2007
    Decision Date
    September 13, 2007
    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 Bio-Rad

    K Number Device Name
    K171061 MRSASelect II
    K122187 VRESELECT CULTURE MEDIUM
    K103684 VRESELECT CULTURE MEDIUM
    K093678 PLATELIA ASPERGILLUS EIA MODEL 62793
    K100589 MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
    K081362 PLATELIA LYME IGM
    K081212 MRSASELECT - EXTENDED INCUBATION
    K080012 PLATELIA LYME IGG ASSAY
    K060641 PLATELIA ASPERGILLUS EIA, MODEL 62793
    K052838 LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
    Search all 319 clearances from Bio-Rad →