BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    IMAGEN INFLUENZA VIRUS A AND B TESTMI

    K Number: K872958 · Decision Feb 24, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    17
    Applicant Total
    20
    Review Days
    210

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    Basic Information

    Device Name
    IMAGEN INFLUENZA VIRUS A AND B TESTMI
    K Number
    K872958
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3330
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Boots-Celltech Diagnostics, Inc.
    Date Received
    July 29, 1987
    Decision Date
    February 24, 1988
    Product Code
    GNX
    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
    GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

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    Other Clearances by Boots-Celltech Diagnostics, Inc.

    K Number Device Name
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    K880758 SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY
    K874875 CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)
    K872843 OVEIA (TM) DUAL ANALYTE
    K873625 CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)
    K872056 MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST
    K870602 IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST
    K864998 IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
    K864539 MODIFIED IMAGEN(TM) CHLAMYDIA TEST
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