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

    MIC-CONCEPT SYSTEM

    K Number: K852613 · Decision Sep 20, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    15
    Applicant Total
    12
    Review Days
    93

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    Basic Information

    Device Name
    MIC-CONCEPT SYSTEM
    K Number
    K852613
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Microtech Medical Systems, Inc.
    Date Received
    June 19, 1985
    Decision Date
    September 20, 1985
    Product Code
    LTW
    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
    LTW Susceptibility Test Cards, Antimicrobial

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    Other Clearances by Microtech Medical Systems, Inc.

    K Number Device Name
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    K896332 SUPPLEMENT TO ANAEROBIC MIC PANEL
    K884831 ANAEROBIC MIC PANEL
    K863847 MIC - CONCEPT(TM) RX-2
    K861774 QUADRA-TITER (TM) I.D. (MODIFICATION)
    K860208 QUADRA-TITER I.D.
    K853745 MIC-CONCEPT VIEWBOX
    K850725 QUADRA TITER MICRO PLATES
    K851020 MIC-CONCEPT INOCULATOR
    Search all 12 clearances from Microtech Medical Systems, Inc. →