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

    CULTURE COLLECTION DEVICE

    K Number: K881105 · Decision Apr 25, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    110
    Applicant Total
    10
    Review Days
    41

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    Basic Information

    Device Name
    CULTURE COLLECTION DEVICE
    K Number
    K881105
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Medical Packaging Corp.
    Date Received
    March 15, 1988
    Decision Date
    April 25, 1988
    Product Code
    JSM
    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
    JSM Culture Media, Non-Propagating Transport

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    K964637 CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA
    K936078 CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED
    K932337 CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM
    K915454 CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
    K870398 PAP-PAK CYTOBRUSH KIT
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