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

    FAS FASTIDIOUS MIC PANEL

    K Number: K935485 · Decision Feb 16, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    12
    Review Days
    458

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    Basic Information

    Device Name
    FAS FASTIDIOUS MIC PANEL
    K Number
    K935485
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Microtech Medical Systems, Inc.
    Date Received
    November 15, 1993
    Decision Date
    February 16, 1995
    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
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    K860208 QUADRA-TITER I.D.
    K852613 MIC-CONCEPT SYSTEM
    K853745 MIC-CONCEPT VIEWBOX
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