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 |