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

    HERPES VIRUS CONTROL SLIDES

    K Number: K883684 · Decision Sep 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    33
    Applicant Total
    11
    Review Days
    30

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    Basic Information

    Device Name
    HERPES VIRUS CONTROL SLIDES
    K Number
    K883684
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Val Tech Diagnostics, Inc.
    Date Received
    August 29, 1988
    Decision Date
    September 28, 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 Val Tech Diagnostics, Inc.

    K Number Device Name
    K883570 HISTO-CHECK FUNGAL CONTROL SLIDES
    K883571 HISTO-CHECK PARASITIC CONTROL SLIDES
    K883569 HISTO-CHECK GRAM NEGATIVE SLIDES
    K883568 HISTO-CHECK ACID FAST SLIDES
    K883567 HISTO-CHECK LEGIONELLA CONTROL SLIDES
    K883232 HISTONE REACTIVE ANA
    K883208 HISTO-CHECK SLIDES
    K871395 DUAL SUBSTRATE ANA
    K864668 ANA TEST KIT
    K870732 RAT LIVER NUCLEI TEST SYSTEM
    Search all 11 clearances from Val Tech Diagnostics, Inc. →