BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM

    K Number: K851528 · Decision Jul 15, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    6
    Applicant Total
    66
    Review Days
    88

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    Basic Information

    Device Name
    PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM
    K Number
    K851528
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Pasco Laboratories, Inc.
    Date Received
    April 18, 1985
    Decision Date
    July 15, 1985
    Product Code
    LQM
    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
    LQM Gram Negative Identification Panel

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    Other Clearances by Pasco Laboratories, Inc.

    K Number Device Name
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    K033119 PASCO MIC AND MIC/ID PANELS
    K031727 PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN
    K031205 PASCO MIC AND MIC/ID PANELS
    K031103 PASCO MIC AND MIC/ID PANELS (ERTAPENEM)
    K030933 PASCO MIC AND MIC/ID PANELS
    K030620 PASCO MIC AND MIC/ID PANELS
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