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

    WELLCOZYME HSV WZO2

    K Number: K875311 · Decision Aug 3, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    33
    Applicant Total
    28
    Review Days
    218

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    Basic Information

    Device Name
    WELLCOZYME HSV WZO2
    K Number
    K875311
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Wellcome Diagnostics
    Date Received
    December 29, 1987
    Decision Date
    August 3, 1988
    Product Code
    GQN
    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
    GQN Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2

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    Other Clearances by Wellcome Diagnostics

    K Number Device Name
    K915203 D-DIMER WELLCOTEST (HA10)
    K910797 STREPTEX ACID EXTRACTION KIT
    K895461 WELLCOLEX COLOUR SHIGELLA TEST ZC51
    K890146 WELLCOLEX COLOUR SALMONELLA TEST ZL 50
    K861628 WELLCOZYME ROTAVIRUS WZ01
    K864206 REVEAL COLOUR STREP A ZL16
    K861634 THE WELLCOME ROTAVIRUS LATEX TEST ZL40
    K854852 WELLCOGEN BACTERIAL ANTIGEN KIT
    K854851 WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24
    K851691 WILLCOGEN MENINGITIDIS KIT ZL25
    Search all 28 clearances from Wellcome Diagnostics →