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

    DRIED GRAM-POSITIVE MIC/COMBO PANELS

    K Number: K944651 · Decision Nov 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    72
    Review Days
    53

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    Basic Information

    Device Name
    DRIED GRAM-POSITIVE MIC/COMBO PANELS
    K Number
    K944651
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Baxter Diagnostics, Inc.
    Date Received
    September 26, 1994
    Decision Date
    November 18, 1994
    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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