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

    ENA SCREENING CIE KIT FOR DIAGNOSTIC USE

    K Number: K924262 · Decision Dec 29, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    177
    Applicant Total
    113
    Review Days
    127

    Basic Information

    Device Name
    ENA SCREENING CIE KIT FOR DIAGNOSTIC USE
    K Number
    K924262
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    THE BINDING SITE, LTD.
    Date Received
    August 24, 1992
    Decision Date
    December 29, 1992
    Product Code
    LLL
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LLL Extractable Antinuclear Antibody, Antigen And Control

    Similar 510(k) Clearances

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

    Aptiva CTD Essential Reagent

    FDA 510(k)
    FDA Class 2 ·Immunology

    EliA SymphonyS Immunoassay

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUANTA Flash HMGCR Reagents

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols

    FDA 510(k)
    FDA Class 2 ·Immunology

    ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA

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

    Other Clearances by THE BINDING SITE, LTD.

    K Number Device Name
    K090920 HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
    K083289 HUMAN BETA-2 MICROGLOBULIN KIT
    K082129 HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
    K081827 HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
    K081674 BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)
    K080384 HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
    K072889 HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
    K070900 FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT
    K062372 FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
    K062183 FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
    Search all 113 clearances from THE BINDING SITE, LTD. →