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

    HEMAGEN ENA SM KIT (EIA METHOD)

    K Number: K946123 · Decision Feb 22, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    177
    Applicant Total
    52
    Review Days
    69

    Basic Information

    Device Name
    HEMAGEN ENA SM KIT (EIA METHOD)
    K Number
    K946123
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HEMAGEN DIAGNOSTICS, INC.
    Date Received
    December 15, 1994
    Decision Date
    February 22, 1995
    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 HEMAGEN DIAGNOSTICS, INC.

    K Number Device Name
    K041052 RAICHEM GLUCOSE UV (LIQUID)
    K041051 RAICHEM BUN RATE REAGENT (LIQUID)
    K041009 RAICHEM CALCIUM (OCPC) LIQUID REAGENT
    K031101 RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2
    K023784 RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
    K022772 RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
    K022767 RAICHEM LIPID CALIBRATOR
    K021194 RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
    K022049 MODIFICATION TO RAICHEM CALCIUM REAGENT
    K012668 RAICHEM GLUCOSE UV REAGENT
    Search all 52 clearances from HEMAGEN DIAGNOSTICS, INC. →