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

    ELVIS HSV ID AND D3 TYPING TEST SYSTEM

    K Number: K091753 · Decision Aug 28, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    36
    Applicant Total
    37
    Review Days
    73

    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
    ELVIS HSV ID AND D3 TYPING TEST SYSTEM
    K Number
    K091753
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diagnostic Hybrids, Inc.
    Date Received
    June 16, 2009
    Decision Date
    August 28, 2009
    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.

    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

    PATHODX HERPES TYPING

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

    Other Clearances by Diagnostic Hybrids, Inc.

    K Number Device Name
    DEN140004 QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
    K092229 THYRETAIN TM TSI REPORTER BIOASSAY
    K093415 D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
    K093233 D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
    K092882 D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
    K091171 D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT
    K092300 MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
    K083391 THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
    K090073 D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT
    K081746 D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT
    Search all 37 clearances from Diagnostic Hybrids, Inc. →