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

    SYNTHETIC VDRL ANTIGEN

    K Number: K993633 · Decision Feb 23, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    31
    Applicant Total
    30
    Review Days
    119

    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
    SYNTHETIC VDRL ANTIGEN
    K Number
    K993633
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3820
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Centers for Disease Control and Prevention
    Date Received
    October 27, 1999
    Decision Date
    February 23, 2000
    Product Code
    GMQ
    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
    GMQ Antigens, Nontreponemal, All

    Similar 510(k) Clearances

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

    Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ASI Automated ASI RPR Test for Syphilis on the ASI Evolution

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ASI Evolution

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST

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

    Other Clearances by Centers for Disease Control and Prevention

    K Number Device Name
    K260812 Francisella tularensis Real-time PCR Assay
    K252072 Francisella tularensis Real-time PCR assay
    K243274 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
    K243931 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
    K241110 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
    K222558 Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
    K221834 Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
    K221658 Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
    K200370 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit
    K192871 B. anthracis Real-time PCR Assay
    Search all 30 clearances from Centers for Disease Control and Prevention →