BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM

    K Number: K944847 · Decision Feb 16, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    11
    Review Days
    139

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    Basic Information

    Device Name
    KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM
    K Number
    K944847
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Starplex Scientific, Inc.
    Date Received
    September 30, 1994
    Decision Date
    February 16, 1995
    Product Code
    JSL
    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
    JSL Culture Media, Anaerobic Transport

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    Other Clearances by Starplex Scientific, Inc.

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    K924362 VACUPLUS TUBES WITH LAVANDER STOPPERS
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