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

    IMAGEN

    K Number: K943557 · Decision Jan 9, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    10
    Applicant Total
    6
    Review Days
    171

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    Basic Information

    Device Name
    IMAGEN
    K Number
    K943557
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3400
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dako Diagnostics , Ltd.
    Date Received
    July 22, 1994
    Decision Date
    January 9, 1995
    Product Code
    GQS
    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
    GQS Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4

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    Other Clearances by Dako Diagnostics , Ltd.

    K Number Device Name
    K981226 IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3
    K973954 IMAGEN RESPIRATORY SCREEN
    K962037 IMAGEN RESPIRATORY SCREEN
    K940564 IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION
    K932384 IDEIA(TM) ROTAVIRUS