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

    SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA

    K Number: K923892 · Decision Jun 21, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    39
    Applicant Total
    12
    Review Days
    321

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    Basic Information

    Device Name
    SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA
    K Number
    K923892
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Smith River Biologicals
    Date Received
    August 4, 1992
    Decision Date
    June 21, 1993
    Product Code
    JSO
    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
    JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

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    Other Clearances by Smith River Biologicals

    K Number Device Name
    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
    K841213 ANTIMICROBIAL SUSCEPT-CULTURE MEDIA
    K841205 NON PROPAGATING TRANSPORT
    Search all 12 clearances from Smith River Biologicals →