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

    PRECEPT TM MOXALACTAM

    K Number: K853689 · Decision Sep 13, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    15
    Applicant Total
    45
    Review Days
    196

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    Basic Information

    Device Name
    PRECEPT TM MOXALACTAM
    K Number
    K853689
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Austin Biological Laboratories
    Date Received
    March 1, 1985
    Decision Date
    September 13, 1985
    Product Code
    LTW
    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
    LTW Susceptibility Test Cards, Antimicrobial

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    K860194 AUSTIN ENTERIC SYSTEM
    K854577 PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN)
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