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

    PASCO MIC AND MIC/ID PANELS

    K Number: K972567 · Decision Aug 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    66
    Review Days
    50

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    Basic Information

    Device Name
    PASCO MIC AND MIC/ID PANELS
    K Number
    K972567
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pasco Laboratories, Inc.
    Date Received
    July 1, 1997
    Decision Date
    August 20, 1997
    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 Pasco Laboratories, Inc.

    K Number Device Name
    K042331 PASCO MIC AND MIC/ID PANELS
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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
    K020331 PASCO MIC AND MIC/ID PANELS
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