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

    INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1

    K Number: K905608 · Decision Nov 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    36
    Applicant Total
    7
    Review Days
    328

    Basic Information

    Device Name
    INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1
    K Number
    K905608
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    STELLAR BIO SYSTEMS, INC.
    Date Received
    December 14, 1990
    Decision Date
    November 7, 1991
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GQL), ordered by most recent decision date.

    ELVIS HSV ID AND D3 TYPING TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH

    FDA 510(k)
    FDA Class 2 ·Microbiology

    THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PATHODX HERPES TYPING

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by STELLAR BIO SYSTEMS, INC.

    K Number Device Name
    K992587 EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM
    K990916 INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY
    K990915 INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY
    K914953 IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY
    K900974 INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.
    K882835 INDIRECT FLUORESCENT ASSAY FOR (HCMV)