FDA 510(k) Applications for Medical Device Product Code "MID"
(System, Test, Anticardiolipin Immunological)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K040463 | AESKU, INC | AESKULISA CARDIOLIPIN AGM | 05/12/2004 |
| K955449 | AMERICAN LABORATORY PRODUCTS CO., LTD. | ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY | 05/23/1996 |
| K962469 | AMERICAN LABORATORY PRODUCTS CO., LTD. | ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY | 09/09/1996 |
| K962926 | AMERICAN LABORATORY PRODUCTS CO., LTD. | ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY | 10/10/1996 |
| K001574 | AXIS-SHIELD | DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 | 06/09/2000 |
| K020156 | AXIS-SHIELD DIAGNOSTICS, LTD. | DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T | 03/06/2002 |
| K001981 | AXIS-SHIELD LTD. | DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 | 08/21/2000 |
| K103834 | Bio-Rad Laboratories | BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS | 03/30/2012 |
| K130528 | Bio-Rad Laboratories | BIOPLEX 2200 APLS IGM | 10/21/2013 |
| K020241 | CHESHIRE DIAGNOSTICS LTD. | QACA IGG/IGM ELISA KIT | 03/13/2002 |
| K021192 | CHESHIRE DIAGNOSTICS LTD. | QACA IGG/IGM ELISA KIT HRP | 05/16/2002 |
| K992440 | COGENT DIAGNOTICS LTD. | AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA | 09/21/1999 |
| K992449 | COGENT DIAGNOTICS LTD. | AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA | 11/24/1999 |
| K993085 | COGENT DIAGNOTICS LTD. | AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA | 02/01/2000 |
| K024195 | CORGENIX, INC. | MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT | 01/03/2003 |
| K012567 | CORGENIX, INC. | MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT | 08/23/2001 |
| K022992 | CORGENIX, INC. | REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 | 09/25/2002 |
| K013018 | CORGENIX, INC. | REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT | 09/20/2001 |
| K022990 | CORGENIX, INC. | REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 | 09/25/2002 |
| K000920 | CORGENIX, INC. | REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT | 04/26/2000 |
| K032868 | CORGENIX, INC. | REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 | 10/14/2003 |
| K024196 | CORGENIX, INC. | REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT | 01/03/2003 |
| K012450 | DIAMEDIX CORP. | DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM | 10/26/2001 |
| K012449 | DIAMEDIX CORP. | DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM | 10/26/2001 |
| K012053 | DIAMEDIX CORP. | DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM | 08/20/2001 |
| K971039 | HEMAGEN DIAGNOSTICS, INC. | HEMAGEN ANTI CARDIOLIPIN SCREEN | 06/03/1997 |
| K946216 | HOGAN & HARTSON | CARDIOLIPIN A EIA TEST SYSTEM | 01/24/1996 |
| K946215 | HOGAN & HARTSON | CARDIOLIPIN G EIA TEST SYSTEM | 01/24/1996 |
| K946217 | HOGAN & HARTSON | CARDIOLIPIN M EIA TEST SYSTEM | 01/24/1996 |
| K030741 | HYCOR BIOMEDICAL LTD. | AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA | 05/01/2003 |
| K970177 | IMMCO DIAGNOSTICS, INC. | ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA | 06/11/1997 |
| K113020 | IMMCO DIAGNOSTICS, INC. | IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS | 10/25/2012 |
| K952522 | IMMUNO PROBE, INC. | CARDIOLIPIN IGA EIA TEST SYSTEM | 02/09/1996 |
| K952523 | IMMUNO PROBE, INC. | CARDIOLIPIN IGG EIA TEST KIT | 02/09/1996 |
| K952521 | IMMUNO PROBE, INC. | CARDIOLIPIN IGM EIA TEST SYSTEM | 02/09/1996 |
| K120817 | INOVA DIAGNOSTICS, INC. | QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA | 02/26/2013 |
| K092181 | INSTRUMENTATION LABORATORY CO. | HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS | 03/11/2010 |
| K984102 | LOUISVILLE APL DIAGNOSTICS, INC. | ACL/APS FACS KIT | 03/18/1999 |
| K021398 | LOUISVILLE APL DIAGNOSTICS, INC. | APL IGA ELISA KIT | 08/27/2002 |
| K091845 | PHADIA US INC. | CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM | 06/07/2010 |
| K131821 | PHADIA US INC. | ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY | 12/23/2013 |
| K020757 | PHARMACIA DEUTSCHLAND GMBH | VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796 | 05/02/2002 |
| K020752 | PHARMACIA DEUTSCHLAND GMBH | VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596 | 05/02/2002 |
| K020758 | PHARMACIA DEUTSCHLAND GMBH | VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 | 05/02/2002 |
| K023433 | PHARMACIA DIAGNOSTICS GMBH & CO. KG | VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 | 11/13/2002 |
| K003069 | QUEST INTL., INC. | ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM | 11/27/2000 |
| K955303 | SHIELD DIAGNOSTICS, LTD. | DIASTAT ANTI-CARDIOLIPIN KIT | 05/30/1996 |
| K983696 | THE BINDING SITE, LTD. | ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT | 02/05/1999 |
| K983692 | THE BINDING SITE, LTD. | ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST | 02/05/1999 |
| K983695 | THE BINDING SITE, LTD. | ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT | 02/05/1999 |
| K983694 | THE BINDING SITE, LTD. | ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT | 02/05/1999 |
| K032240 | THE BINDING SITE, LTD. | BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT | 09/29/2003 |
| K060176 | THERATEST LABORATORIES, INC. | EL-ACL SCREEN; EL-ACL IGM, IGG, IGA | 02/07/2006 |
| K984173 | ZEUS SCIENTIFIC, INC. | THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM | 12/22/1998 |
| K984347 | ZEUS SCIENTIFIC, INC. | THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F | 12/17/1998 |
| K984175 | ZEUS SCIENTIFIC, INC. | THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM | 12/17/1998 |
| K981021 | ZEUS SCIENTIFIC, INC. | ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM | 06/02/1998 |
| K981020 | ZEUS SCIENTIFIC, INC. | ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM | 05/18/1998 |
| K102425 | ZEUS SCIENTIFIC, INC. | ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM | 12/12/2011 |
| K981014 | ZEUS SCIENTIFIC, INC. | ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM | 06/02/1998 |
| K973196 | ZEUS SCIENTIFIC, INC. | ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS | 10/29/1997 |
| K971784 | ZEUS SCIENTIFIC, INC. | ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM | 07/23/1997 |
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