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

    HSV-2 ELISA TEST SYSTEM

    K Number: K891782 · Decision Jun 20, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    36
    Applicant Total
    135
    Review Days
    88

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    HSV-2 ELISA TEST SYSTEM
    K Number
    K891782
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Zeus Scientific, Inc.
    Date Received
    March 24, 1989
    Decision Date
    June 20, 1989
    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

    INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING

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

    Other Clearances by Zeus Scientific, Inc.

    K Number Device Name
    K201956 Zeus IFA ANA HEp-2 Test System, Zeus dIFine
    K190907 ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System
    K191240 ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System
    K191398 ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System
    K113397 ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
    K102425 ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
    K103603 ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
    K103363 ZEUS ELISA HSV GC-I IGG TEST SYSTEM
    K102283 ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM
    K093784 ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM
    Search all 135 clearances from Zeus Scientific, Inc. →