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

    VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT

    K Number: K992224 · Decision Aug 30, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    45
    Applicant Total
    52
    Review Days
    60

    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
    VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT
    K Number
    K992224
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemagen Diagnostics, Inc.
    Date Received
    July 1, 1999
    Decision Date
    August 30, 1999
    Product Code
    MSV
    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
    MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

    Similar 510(k) Clearances

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

    Aptiva APS IgA Reagent

    FDA 510(k)
    FDA Class 2 ·Immunology

    EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay

    FDA 510(k)
    FDA Class 2 ·Immunology

    ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS.

    FDA 510(k)
    FDA Class 2 ·Immunology

    ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY

    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
    K012649 RAICHEM BUN RATE REAGENT
    Search all 52 clearances from Hemagen Diagnostics, Inc. →