Panels › Immunology › Product code MOI · Class 2
System, Test, Immunological, Antigen, Tumor
Regulation 866.6010
0510(k)s in 12 months (28 all time)
0recalls in 12 months (18 all time)
18recalls that name a 510(k)
Top companies in MOI
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Healthcare Diagnostics | 3 | 11 |
| Beckman Coulter, Inc. | 3 | 1 |
| Roche Diagnostics | 4 | 0 |
| Abbott Laboratories | 2 | 1 |
| Abbott Laboratories HPD/ADD | 0 | 3 |
| Chiron Diagnostics Corp. | 3 | 0 |
| Bayer Diagnostics Corp. | 2 | 0 |
| Chiron Corp. | 2 | 0 |
| Fujirebio Diagnostics,Inc. | 2 | 0 |
| Abbott Laboratories MPG | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 9, 2024 | K240403 | Access BR Monitor Beckman Coulter, Inc. | MOI |
| Mar 13, 2024 | K233946 | IMMULITE® 2000 BR-MA Siemens Healthcare Diagnostics Products, Ltd., GB | MOI |
| Sep 4, 2020 | K192524 | Lumipulse G CA15-3 Fujirebio Diagnostics,Inc. | MOI |
| Feb 13, 2020 | K193489 | ADVIA Centaur BR Siemens Healthcare Diagnostics, Inc. | MOI |
| Nov 22, 2019 | K192777 | ADVIA Centaur CA 15-3 assay Siemens Healthcare Diagnostics, Inc. | MOI |
| Jun 22, 2018 | K181492 | Elecsys CA 15-3 II Roche Diagnostics | MOI |
| Feb 20, 2018 | K171605 | Elecsys CA 15-3 II Roche Diagnostics | MOI |
| Apr 18, 2011 | K100344 | DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 Siemens Healthcare Diagnostics | MOI |
| Oct 26, 2007 | K072612 | ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 Beckman Coulter, Inc. | MOI |
| Dec 22, 2004 | K042732 | ARCHITECT CA 15-3 ASSAY Fujirebio Diagnostics,Inc. | MOI |
| Feb 3, 2004 | K033036 | BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 Beckman Coulter, Inc. | MOI |
| Nov 12, 2002 | K022178 | CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Diagnostics Corp. | MOI |
| Mar 28, 2002 | K013984 | IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR Diagnostic Products Corp. | MOI |
| Feb 28, 2002 | K012357 | CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM Bayer Diagnostics Corp. | MOI |
| Aug 16, 2001 | K010796 | AIA-PACK BRCA, ST AIA PACK BRCA Tosoh Medics, Inc. | MOI |
| Mar 28, 2001 | K010588 | ELECSYSCA 15-3 II ASSAY Roche Diagnostics Corp. | MOI |
| Oct 23, 2000 | K001468 | ELECSYS CA 15-3 TEST SYSTEM Roche Diagnostics Corp. | MOI |
| Feb 2, 1999 | K983690 | VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK Ortho-Clinical Diagnostics, Inc. | MOI |
| Oct 15, 1998 | K982680 | CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY Chiron Diagnostics Corp. | MOI |
| Jul 10, 1998 | K981698 | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) Chiron Corp. | MOI |
| Mar 6, 1998 | K980190 | ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM) Chiron Corp. | MOI |
| Dec 1, 1997 | K964703 | THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) Bayer Corp. | MOI |
| Nov 10, 1997 | K964407 | IMX CA 15-3 Abbott Laboratories | MOI |
| Oct 31, 1997 | K965141 | TRUQUANT BR RIA Biomira USA, Inc. | MOI |
| Sep 15, 1997 | K963926 | AXSYM CA 15-3 Abbott Laboratories | MOI |
| Aug 8, 1997 | K970695 | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) Chiron Diagnostics Corp. | MOI |
| Jul 17, 1997 | K971418 | CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER Chiron Diagnostics Corp. | MOI |
| May 23, 1997 | K963803 | CENTOCOR CA 15-3 RIA MODEL NO. 800-033 Centocor, Inc. | MOI |
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