BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    LYOPHILIZED MICROORGANISMS

    K Number: K831653 · Decision Jul 28, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    11
    Applicant Total
    45
    Review Days
    66

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    Basic Information

    Device Name
    LYOPHILIZED MICROORGANISMS
    K Number
    K831653
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2480
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Austin Biological Laboratories
    Date Received
    May 23, 1983
    Decision Date
    July 28, 1983
    Product Code
    JTR
    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
    JTR Kit, Quality Control For Culture Media

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