ClearanceBrief
Panels › Immunology › Product code MID · Class 2

System, Test, Anticardiolipin Immunological

Regulation 866.5660

0510(k)s in 12 months (94 all time)
0recalls in 12 months (17 all time)
16recalls that name a 510(k)
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Top companies in MID

Company510(k)sRecalls
Zeus Scientific, Inc.92
Inova Diagnostics, Inc.90
Louisville Apl Diagnostics, Inc.36
Corgenix, Inc.80
Elias U.S.A., Inc.70
The Binding Site, Ltd.51
Immco Diagnostics, Inc.50
Immunoprobe, Inc.50
American Laboratory Products Co., Ltd.30
Bio-Rad Laboratories21
Decided510(k)Device and applicantCode
Dec 17, 2024K223093Aptiva APS IgG Reagent; Aptiva APS IgM Reagent
Inova Diagnostics, Inc.
MID
Dec 23, 2013K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
Phadia US, Inc.
MID
Oct 21, 2013K130528BIOPLEX 2200 APLS IGM
Bio-Rad Laboratories
MID
Feb 26, 2013K120817QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
Inova Diagnostics, Inc.
MID
Oct 25, 2012K113020IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
Immco Diagnostics, Inc.
MID
Mar 30, 2012K103834BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
Bio-Rad Laboratories
MID
Dec 12, 2011K102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
Zeus Scientific, Inc.
MID
Jun 7, 2010K091845CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
Phadia US, Inc.
MID
Mar 11, 2010K092181HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
Instrumentation Laboratory CO
MID
Feb 7, 2006K060176EL-ACL SCREEN; EL-ACL IGM, IGG, IGA
Theratest Laboratories, Inc.
MID
May 12, 2004K040463AESKULISA CARDIOLIPIN AGM
Aesku, Inc.
MID
Oct 14, 2003K032868REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
Corgenix, Inc.
MID
Sep 29, 2003K032240BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
The Binding Site, Ltd.
MID
May 1, 2003K030741AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA
Hycor Biomedical , Ltd., GB
MID
Jan 3, 2003K024196REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
Corgenix, Inc.
MID
Jan 3, 2003K024195MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT
Corgenix, Inc.
MID
Nov 13, 2002K023433VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896
Pharmacia Diagnostics GmbH & Co. KG, DE
MID
Sep 25, 2002K022992REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
Corgenix, Inc.
MID
Sep 25, 2002K022990REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001
Corgenix, Inc.
MID
Aug 27, 2002K021398APL IGA ELISA KIT
Louisville Apl Diagnostics, Inc.
MID
May 16, 2002K021192QACA IGG/IGM ELISA KIT HRP
Cheshire Diagnostics , Ltd., GB
MID
May 2, 2002K020758VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
Pharmacia Deutschland GmbH, DE
MID
May 2, 2002K020757VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796
Pharmacia Deutschland GmbH, DE
MID
May 2, 2002K020752VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596
Pharmacia Deutschland GmbH, DE
MID
Mar 13, 2002K020241QACA IGG/IGM ELISA KIT
Cheshire Diagnostics , Ltd., GB
MID
Mar 6, 2002K020156DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
Axis-Shield Diagnostics, Ltd., GB
MID
Oct 26, 2001K012450DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
Diamedix Corp.
MID
Oct 26, 2001K012449DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
Diamedix Corp.
MID
Sep 20, 2001K013018REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT
Corgenix, Inc.
MID
Aug 23, 2001K012567MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
Corgenix, Inc.
MID
Aug 20, 2001K012053DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
Diamedix Corp.
MID
Nov 27, 2000K003069ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
Quest Intl., Inc.
MID
Aug 21, 2000K001981DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500
Axis-Shield , Ltd., GB
MID
Jun 9, 2000K001574DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
Axis-Shield, GB
MID
Apr 26, 2000K000920REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT
Corgenix, Inc.
MID
Feb 1, 2000K993085AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA
Cogent Diagnotics , Ltd.
MID
Nov 24, 1999K992449AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
Cogent Diagnotics , Ltd., GB
MID
Sep 21, 1999K992440AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA
Cogent Diagnotics , Ltd., GB
MID
Mar 18, 1999K984102ACL/APS FACS KIT
Louisville Apl Diagnostics, Inc.
MID
Feb 5, 1999K983696ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT
The Binding Site, Ltd.
MID
Feb 5, 1999K983695ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT
The Binding Site, Ltd.
MID
Feb 5, 1999K983694ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT
The Binding Site, Ltd.
MID
Feb 5, 1999K983692ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST
The Binding Site, Ltd.
MID
Dec 22, 1998K984173THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM
Zeus Scientific, Inc.
MID
Dec 17, 1998K984347THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F
Zeus Scientific, Inc.
MID
Dec 17, 1998K984175THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM
Zeus Scientific, Inc.
MID
Jun 2, 1998K981021ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM
Zeus Scientific, Inc.
MID
Jun 2, 1998K981014ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM
Zeus Scientific, Inc.
MID
May 18, 1998K981020ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM
Zeus Scientific, Inc.
MID
Oct 29, 1997K973196ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS
Zeus Scientific, Inc.
MID

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