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

    ISOLATION OF PATHOGENIC NEISSERIA

    K Number: K820847 · Decision Apr 16, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    82
    Applicant Total
    11
    Review Days
    21

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    Basic Information

    Device Name
    ISOLATION OF PATHOGENIC NEISSERIA
    K Number
    K820847
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.2410
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Blue Ridge Media Co.
    Date Received
    March 26, 1982
    Decision Date
    April 16, 1982
    Product Code
    JTY
    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
    JTY Culture Media, For Isolation Of Pathogenic Neisseria

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    Other Clearances by Blue Ridge Media Co.

    K Number Device Name
    K820843 CULTURE MEDIA SELECTIVE BROTH
    K820839 CULTURE MEDIA, SINGLE BIOCHEM. TEST
    K820848 BLUE RIDGE SHEEP BLOOD
    K820841 CULTURE MEDIA, MULTIPLE BIOCHEMICAL
    K820845 DULTURE MEDIA, SELECTIVE & NON-DIFFER
    K820844 CULTURE MEDIA, SELECTIVE & DIFFERENTIAL
    K820846 ANTIMICROBIAL SUSCEP. TEST, MUELLER
    K820842 CULTURE MEDIA, NON-SELECTIVE/DIFFER
    K820840 CULTURE MEDIA, GENERAL NUTRIENT BROTH
    K820849 BLUE RIDGE RABBIT BLOOD
    Search all 11 clearances from Blue Ridge Media Co. →