Atlas FDA

MID

94 FDA 510(k) clearances · Product code

90 daysmedian time to decision
399 days90th percentile
94clearances measured

FDA profile

Official device name
System, Test, Anticardiolipin Immunological
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5660
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
Aptiva APS IgG Reagent; Aptiva APS IgM Reagent (K223093)Inova Diagnostics, Inc.2024-12-17
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY (K131821)Phadia US, Inc.2013-12-23
BIOPLEX 2200 APLS IGM (K130528)Bio-Rad Laboratories2013-10-21
QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA (K120817)Inova Diagnostics, Inc.2013-02-26
IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS (K113020)Immco Diagnostics, Inc.2012-10-25
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS (K103834)Bio-Rad Laboratories2012-03-30
ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM (K102425)Zeus Scientific, Inc.2011-12-12
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM (K091845)Phadia US, Inc.2010-06-07
HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS (K092181)Instrumentation Laboratory CO2010-03-11
EL-ACL SCREEN; EL-ACL IGM, IGG, IGA (K060176)Theratest Laboratories, Inc.2006-02-07
AESKULISA CARDIOLIPIN AGM (K040463)Aesku, Inc.2004-05-12
REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 (K032868)Corgenix, Inc.2003-10-14
BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT (K032240)The Binding Site, Ltd.2003-09-29
AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA (K030741)Hycor Biomedical , Ltd.2003-05-01
MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT (K024195)Corgenix, Inc.2003-01-03
REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT (K024196)Corgenix, Inc.2003-01-03
VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 (K023433)Pharmacia Diagnostics GmbH & Co. KG2002-11-13
REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 (K022992)Corgenix, Inc.2002-09-25
REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 (K022990)Corgenix, Inc.2002-09-25
APL IGA ELISA KIT (K021398)Louisville Apl Diagnostics, Inc.2002-08-27
QACA IGG/IGM ELISA KIT HRP (K021192)Cheshire Diagnostics , Ltd.2002-05-16
VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596 (K020752)Pharmacia Deutschland GmbH2002-05-02
VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796 (K020757)Pharmacia Deutschland GmbH2002-05-02
VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 (K020758)Pharmacia Deutschland GmbH2002-05-02
QACA IGG/IGM ELISA KIT (K020241)Cheshire Diagnostics , Ltd.2002-03-13
DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T (K020156)Axis-Shield Diagnostics, Ltd.2002-03-06
DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM (K012449)Diamedix Corp.2001-10-26
DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM (K012450)Diamedix Corp.2001-10-26
REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT (K013018)Corgenix, Inc.2001-09-20
MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT (K012567)Corgenix, Inc.2001-08-23
DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM (K012053)Diamedix Corp.2001-08-20
ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM (K003069)Quest Intl., Inc.2000-11-27
DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 (K001981)Axis-Shield , Ltd.2000-08-21
DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 (K001574)Axis-Shield2000-06-09
REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT (K000920)Corgenix, Inc.2000-04-26
AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA (K993085)Cogent Diagnotics , Ltd.2000-02-01
AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA (K992449)Cogent Diagnotics , Ltd.1999-11-24
AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA (K992440)Cogent Diagnotics , Ltd.1999-09-21
ACL/APS FACS KIT (K984102)Louisville Apl Diagnostics, Inc.1999-03-18
ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT (K983694)The Binding Site, Ltd.1999-02-05
ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST (K983692)The Binding Site, Ltd.1999-02-05
ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT (K983695)The Binding Site, Ltd.1999-02-05
ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT (K983696)The Binding Site, Ltd.1999-02-05
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM (K984173)Zeus Scientific, Inc.1998-12-22
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F (K984347)Zeus Scientific, Inc.1998-12-17
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM (K984175)Zeus Scientific, Inc.1998-12-17
ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM (K981021)Zeus Scientific, Inc.1998-06-02
ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM (K981014)Zeus Scientific, Inc.1998-06-02
ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM (K981020)Zeus Scientific, Inc.1998-05-18
ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS (K973196)Zeus Scientific, Inc.1997-10-29
ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM (K971784)Zeus Scientific, Inc.1997-07-23
ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA (K970177)Immco Diagnostics, Inc.1997-06-11
HEMAGEN ANTI CARDIOLIPIN SCREEN (K971039)Hemagen Diagnostics, Inc.1997-06-03
ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY (K962926)American Laboratory Products Co., Ltd.1996-10-10
ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY (K962469)American Laboratory Products Co., Ltd.1996-09-09
DIASTAT ANTI-CARDIOLIPIN KIT (K955303)Shield Diagnostics, Ltd.1996-05-30
ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY (K955449)American Laboratory Products Co., Ltd.1996-05-23
CARDIOLIPIN IGG EIA TEST KIT (K952523)Immunoprobe, Inc.1996-02-09
CARDIOLIPIN IGM EIA TEST SYSTEM (K952521)Immunoprobe, Inc.1996-02-09
CARDIOLIPIN IGA EIA TEST SYSTEM (K952522)Immunoprobe, Inc.1996-02-09
CARDIOLIPIN M EIA TEST SYSTEM (K946217)Hogan & Hartson1996-01-24
CARDIOLIPIN G EIA TEST SYSTEM (K946215)Hogan & Hartson1996-01-24
CARDIOLIPIN A EIA TEST SYSTEM (K946216)Hogan & Hartson1996-01-24
REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT (K952287)Reaads Medical Products, Inc.1995-12-18
CARDIOLIPIN IGG,M,A EIA TEST SYSTEM (K951363)Immunoprobe, Inc.1995-10-13
VARELISA CARDIOLIPIN ABS SCREEN (K951187)Elias U.S.A., Inc.1995-10-02
CARDIOLIPIN IGG,M,A EIA TEST KIT (K952520)Immunoprobe, Inc.1995-09-15
QUANTA LITE IGA ACA (HRP) (K953366)Inova Diagnostics, Inc.1995-09-01
QUANTA LITE ACA SCREEN (HRP) (K953291)Inova Diagnostics, Inc.1995-08-29
QUANTA LITE ACA IGM (HRP) (K946385)Inova Diagnostics, Inc.1995-07-18
QUANTA LITE(TM) IGG (HRP) (K946034)Inova Diagnostics, Inc.1995-07-18
ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST (K933786)Immco Diagnostics, Inc.1995-03-07
ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST (K933788)Immco Diagnostics, Inc.1995-03-07
ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST) (K933784)Immco Diagnostics, Inc.1995-03-07
APHLELISA KIT (K933588)Louisville Apl Diagnostics, Inc.1994-10-13
ELIAS CARDIOLIPIN ANTIBODIES (K940403)Elias U.S.A., Inc.1994-09-20
HEMAGEN ACL IGA CALIBRATOR (K941840)Hemagen Diagnostics, Inc.1994-06-30
SYNELISA CARDIOLIPIN ANTIBODIES (K935288)Elias U.S.A., Inc.1994-01-24
ELIAS CARDIOLIPIN IGM ANTIBODIES (K933392)Elias U.S.A., Inc.1993-12-08
ELIAS CARDIOLIPIN IGG ANTIBODIES (K933393)Elias U.S.A., Inc.1993-12-08
HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0 (K932373)Hemagen Diagnostics, Inc.1993-07-16
ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM (K932225)Immuno Concepts, Inc.1993-07-06
SYNELISA CARDIOLIPIN ANTIBODIES (K924421)Elias U.S.A., Inc.1992-11-30
QUANTA LITE(TM) IGA ACA (K922351)Inova Diagnostics, Inc.1992-09-29
QUANTA LITE ACA SCREEN (K923320)Inova Diagnostics, Inc.1992-09-28
DIASTAT TOTAL ANTI-CARDIOLIPIN KIT (K923886)Shield Diagnostics, Ltd.1992-09-25
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST (K920401)General Biometrics, Inc.1992-08-20
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST (K920400)General Biometrics, Inc.1992-08-20
DIASTAT ANTI-CARDIOLIPIN KIT (K921265)Shield Diagnostics, Ltd.1992-08-03
SYNELISA CARDIOLIPIN ANTIBODIES (K921250)Elias U.S.A., Inc.1992-06-04
READS(R) IGA ANTI-CARDIOLIPIN TEST KIT (K914405)Reads Medical Products, Inc.1991-12-18
ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM (K911661)Immuno Concepts, Inc.1991-12-09
3M ANTI-CARDIOLIPIN FAST(TM) TEST (K913054)3M Diagnostic Systems, Inc.1991-11-27
QUANTA LITE(TM) ACA (K911680)Inova Diagnostics, Inc.1991-11-19

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