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

    CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP

    K Number: K831179 · Decision May 9, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    327
    Applicant Total
    39
    Review Days
    28

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    Basic Information

    Device Name
    CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP
    K Number
    K831179
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1620
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    General Diagnostics
    Date Received
    April 11, 1983
    Decision Date
    May 9, 1983
    Product Code
    JTN
    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
    JTN Susceptibility Test Discs, Antimicrobial

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    K864993 QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE
    K863877 BENZODIAZEPINE ENZYME IMMUNOASSAY KIT
    K842307 GENERAL DIAG. CEFONICID 30MCG ANTIMIC
    K841465 GENERAL DIAGNOSTICS PLATELET ANTIBODY
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    K832653 CEFUROXIME 30MCG. SUSCEP DISK
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