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

    HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2

    K Number: K870814 · Decision Jun 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    36
    Applicant Total
    11
    Review Days
    93

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    Basic Information

    Device Name
    HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2
    K Number
    K870814
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Microscan Div. Baxter Healthcare Corp.
    Date Received
    March 3, 1987
    Decision Date
    June 4, 1987
    Product Code
    GQL
    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
    GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2

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    Other Clearances by Microscan Div. Baxter Healthcare Corp.

    K Number Device Name
    K871232 ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3
    K871231 ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B
    K871228 ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2
    K871230 ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS
    K871233 ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A
    K871229 ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL
    K871234 ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1
    K870074 GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS
    K871033 RABBIT KIDNEY CULTURE CELLS (FIRST PASS)
    K870089 IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT
    Search all 11 clearances from Microscan Div. Baxter Healthcare Corp. →