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

    ANTIMICROBIAL SUSCEPT-CULTURE MEDIA

    K Number: K841213 · Decision Apr 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    73
    Applicant Total
    12
    Review Days
    23

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    Basic Information

    Device Name
    ANTIMICROBIAL SUSCEPT-CULTURE MEDIA
    K Number
    K841213
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Smith River Biologicals
    Date Received
    March 12, 1984
    Decision Date
    April 4, 1984
    Product Code
    JTZ
    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
    JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

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    MUELLER HINTON AGAR W/OXACILLIN

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    Other Clearances by Smith River Biologicals

    K Number Device Name
    K923892 SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA
    K841207 NON-SELECTIVE & NON-DIFFERENTIAL
    K841209 SELECTIVE AND DIFFERENTIAL
    K841204 MULTIPLE BIOCHEMICAL TEST
    K841206 NON-SELECTIVE & DIFFERENTIAL
    K841211 SELECTIVE BROTH
    K841208 PROPAGATING TRANSPORT
    K841210 SELECTIVE & NON-DIFFERENTIAL
    K841212 SINGLE BIOCHEMICAL TEST
    K841205 NON PROPAGATING TRANSPORT
    Search all 12 clearances from Smith River Biologicals →