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

    LORACARBEF GRAM-NAGATIVE PANELS

    K Number: K940917 · Decision Feb 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    72
    Review Days
    348

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    Basic Information

    Device Name
    LORACARBEF GRAM-NAGATIVE PANELS
    K Number
    K940917
    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
    February 25, 1994
    Decision Date
    February 8, 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 Baxter Diagnostics, Inc.

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    K935704 DRIED GRAM-NEGATIVE MIC//COMBO PANELS
    K950570 STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY
    K945235 DRIED GRAM-POSITIVE MIC/COMBO PANELS
    K941030 DRIED GRAM-NEGATIVE CEFPODOXIME
    K941459 GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX
    K941317 DRIED GRAM NEGATIVE/CEFMETAZOLE
    K942089 MICRODILUTION/LORACARBEF PANELS
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