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

    GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS

    K Number: K870074 · Decision Apr 14, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    11
    Review Days
    96

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    Basic Information

    Device Name
    GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS
    K Number
    K870074
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Microscan Div. Baxter Healthcare Corp.
    Date Received
    January 8, 1987
    Decision Date
    April 14, 1987
    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 Microscan Div. Baxter Healthcare Corp.

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    K871230 ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS
    K871233 ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A
    K871229 ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL
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