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

    WELLCOZYME ROTAVIRUS WZ01

    K Number: K861628 · Decision Jan 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    32
    Applicant Total
    28
    Review Days
    267

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    WELLCOZYME ROTAVIRUS WZ01
    K Number
    K861628
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3405
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Wellcome Diagnostics
    Date Received
    April 29, 1986
    Decision Date
    January 21, 1987
    Product Code
    LIQ
    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
    LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LIQ), ordered by most recent decision date.

    SAS ROTA TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    VIDAS ROTAVIRUS (RTV) ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    IMMUNOCARD STAT! ROTAVIRUS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ROTAVIRUS EIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    VIDAS ROTAVIRUS ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ROTA-DAN RAPID ROTAVIRUS EIA KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    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
    K875311 WELLCOZYME HSV WZO2
    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 →