BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST

    K Number: K870602 · Decision May 8, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    33
    Applicant Total
    20
    Review Days
    86

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    Basic Information

    Device Name
    IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST
    K Number
    K870602
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Boots-Celltech Diagnostics, Inc.
    Date Received
    February 11, 1987
    Decision Date
    May 8, 1987
    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 Boots-Celltech Diagnostics, Inc.

    K Number Device Name
    K871877 IDEIA HERPES SIMPLEX VIRUS TEST
    K880799 MODIFIED IDEIA CHLAMYDIA TEST
    K880758 SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY
    K874875 CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)
    K872958 IMAGEN INFLUENZA VIRUS A AND B TESTMI
    K872843 OVEIA (TM) DUAL ANALYTE
    K873625 CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)
    K872056 MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST
    K864998 IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
    K864539 MODIFIED IMAGEN(TM) CHLAMYDIA TEST
    Search all 20 clearances from Boots-Celltech Diagnostics, Inc. →