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

    MIC - CONCEPT(TM) RX-2

    K Number: K863847 · Decision Dec 18, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    12
    Review Days
    79

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    Basic Information

    Device Name
    MIC - CONCEPT(TM) RX-2
    K Number
    K863847
    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
    September 30, 1986
    Decision Date
    December 18, 1986
    Product Code
    JWY
    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
    JWY Manual Antimicrobial Susceptibility Test Systems

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    Other Clearances by Microtech Medical Systems, Inc.

    K Number Device Name
    K935485 FAS FASTIDIOUS MIC PANEL
    K901598 FASTIDIOUS MIC PANEL
    K896332 SUPPLEMENT TO ANAEROBIC MIC PANEL
    K884831 ANAEROBIC MIC PANEL
    K861774 QUADRA-TITER (TM) I.D. (MODIFICATION)
    K860208 QUADRA-TITER I.D.
    K852613 MIC-CONCEPT SYSTEM
    K853745 MIC-CONCEPT VIEWBOX
    K850725 QUADRA TITER MICRO PLATES
    K851020 MIC-CONCEPT INOCULATOR
    Search all 12 clearances from Microtech Medical Systems, Inc. →