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

    INDIRECT FLUORO-KIT HSV

    K Number: K830623 · Decision Jul 7, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    36
    Applicant Total
    30
    Review Days
    129

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    Basic Information

    Device Name
    INDIRECT FLUORO-KIT HSV
    K Number
    K830623
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Clinical Sciences, Inc.
    Date Received
    February 28, 1983
    Decision Date
    July 7, 1983
    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 Clinical Sciences, Inc.

    K Number Device Name
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    K883871 EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590
    K891990 RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600
    K883600 EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550
    K883601 EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550
    K874594 TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560
    K872942 IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530
    K860145 RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540
    K860773 TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560
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