FDA 510(k) Applications for Medical Device Product Code "MSV"
(System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi))

FDA 510(k) Number Applicant Device Name Decision Date
K062217 AESKU, INC AESKULSKA BETA2-GLYCO-A 12/13/2006
K031177 AXIS-SHIELD DIAGNOSTICS, LTD. DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M 06/19/2003
K020695 CHESHIRE DIAGNOSTICS LTD. QAB2A IGG ELISA KIT 04/19/2002
K021611 CHESHIRE DIAGNOSTICS LTD. QAB2A IGG ELISA KIT HRP 07/12/2002
K021610 CHESHIRE DIAGNOSTICS LTD. QAB2A IGM ELISA KIT HRP 07/12/2002
K072032 CORGENIX, INC. IGG ANTI-ATHEROX TEST KIT 04/04/2008
K013079 CORGENIX, INC. REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT 09/28/2001
K013080 CORGENIX, INC. REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT 09/28/2001
K013077 CORGENIX, INC. REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT 09/28/2001
K982434 CORGENIX, INC. REAADS IGA ANTI-B2GP 1 TEST KIT 12/22/1998
K982391 CORGENIX, INC. REAADS IGG ANTI-B2GPI TEST KIT 12/07/1998
K982433 CORGENIX, INC. REAADS IGM ANTI-B2GP1 TEST KIT 12/07/1998
K031208 CORGENIX, INC. REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 07/07/2003
K013628 DIAMEDIX CORP. DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM 12/21/2001
K013956 DIAMEDIX CORP. DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN 01/08/2002
K992241 HEMAGEN DIAGNOSTICS, INC. VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT 08/30/1999
K992224 HEMAGEN DIAGNOSTICS, INC. VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT 08/30/1999
K992243 HEMAGEN DIAGNOSTICS, INC. VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT 08/30/1999
K030397 HYCOR BIOMEDICAL LTD. AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA 03/21/2003
K022945 HYCOR BIOMEDICAL, INC. AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA 12/18/2002
K022944 HYCOR BIOMEDICAL, INC. AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA 12/18/2002
K030701 IMMCO DIAGNOSTICS, INC. IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA 09/09/2003
K030702 IMMCO DIAGNOSTICS, INC. IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA 09/09/2003
K162788 IMMCO DIAGNOSTICS, INC. 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 06/19/2017
K141274 INOVA DIAGNOSTICS, INC. QUANTA FLASH ┐2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-┐2GPI DOMAIN1; CONTROLS. 02/13/2015
K152875 INOVA DIAGNOSTICS, INC. QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls 12/21/2015
K973006 INOVA DIAGNOSTICS, INC. QUANTA LITE B2 GPI IGA 10/20/1997
K980230 INOVA DIAGNOSTICS, INC. QUANTA LITE B2 GPI SCREEN 03/24/1998
K970551 INOVA DIAGNOSTICS, INC. QUANTA LITE B2GPI IGG 06/24/1997
K973014 INOVA DIAGNOSTICS, INC. QUANTA LITE B2GPI IGM 10/20/1997
K091556 INSTRUMENTATION LABORATORY CO. HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS 05/21/2010
K181329 Phadia AB EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay 06/25/2018
K112414 PHADIA US INC. ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY 06/22/2012
K040452 PHARMACIA DEUTSCHLAND GMBH VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096 05/11/2004
K040450 PHARMACIA DEUTSCHLAND GMBH VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 05/11/2004
K040449 PHARMACIA DEUTSCHLAND GMBH VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 05/11/2004
K040451 PHARMACIA DEUTSCHLAND GMBH VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 05/11/2004
K982879 SHIELD DIAGNOSTICS, LTD. SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY 10/15/1998
K991803 THE BINDING SITE, LTD. BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT. 05/05/2000
K991802 THE BINDING SITE, LTD. BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT 05/05/2000
K991801 THE BINDING SITE, LTD. BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT 05/05/2000
K991804 THE BINDING SITE, LTD. BINDAZYME ANTI-B2 SCREEN EIA TEST KIT. 05/05/2000
K092757 THERA-TEST LABORATORIES INC. THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR 10/09/2009
K973882 THERATEST LABORATORIES, INC. EL-B2GP1SCR 12/05/1997
K972790 THERATEST LABORATORIES, INC. THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR 12/05/1997


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