FDA Product Code
FDA Product Code MOI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.6010
510(k) Clearances — 28 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240403 | Access BR Monitor | Beckman Coulter, Inc. | 2024-05-09 | Traditional | PDF ↗ |
| K233946 | IMMULITE® 2000 BR-MA | Siemens Healthcare Diagnostics Products, Ltd. | 2024-03-13 | Traditional | PDF ↗ |
| K192524 | Lumipulse G CA15-3 | Fujirebio Diagnostics,Inc. | 2020-09-04 | Traditional | PDF ↗ |
| K193489 | ADVIA Centaur BR | Siemens Healthcare Diagnostics, Inc. | 2020-02-13 | Traditional | PDF ↗ |
| K192777 | ADVIA Centaur CA 15-3 assay | Siemens Healthcare Diagnostics, Inc. | 2019-11-22 | Traditional | PDF ↗ |
| K181492 | Elecsys CA 15-3 II | Roche Diagnostics | 2018-06-22 | Traditional | PDF ↗ |
| K171605 | Elecsys CA 15-3 II | Roche Diagnostics | 2018-02-20 | Traditional | PDF ↗ |
| K100344 | DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 | Siemens Healthcare Diagnostics | 2011-04-18 | Traditional | PDF ↗ |
| K072612 | ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 | Beckman Coulter, Inc. | 2007-10-26 | Special | PDF ↗ |
| K042732 | ARCHITECT CA 15-3 ASSAY | Fujirebio Diagnostics,Inc. | 2004-12-22 | Traditional | PDF ↗ |
| K033036 | BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 | Beckman Coulter, Inc. | 2004-02-03 | Traditional | PDF ↗ |
| K022178 | CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-11-12 | Traditional | PDF ↗ |
| K013984 | IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR | Diagnostic Products Corp. | 2002-03-28 | Traditional | PDF ↗ |
| K012357 | CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM | Bayer Diagnostics Corp. | 2002-02-28 | Traditional | PDF ↗ |
| K010796 | AIA-PACK BRCA, ST AIA PACK BRCA | Tosoh Medics, Inc. | 2001-08-16 | Traditional | PDF ↗ |
| K010588 | ELECSYSCA 15-3 II ASSAY | Roche Diagnostics Corp. | 2001-03-28 | Special | PDF ↗ |
| K001468 | ELECSYS CA 15-3 TEST SYSTEM | Roche Diagnostics Corp. | 2000-10-23 | Traditional | PDF ↗ |
| K983690 | VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK | Ortho-Clinical Diagnostics, Inc. | 1999-02-02 | Traditional | PDF ↗ |
| K982680 | CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY | Chiron Diagnostics Corp. | 1998-10-15 | Traditional | PDF ↗ |
| K981698 | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) | Chiron Corp. | 1998-07-10 | Traditional | PDF ↗ |
| K980190 | ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM) | Chiron Corp. | 1998-03-06 | Traditional | PDF ↗ |
| K964703 | THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | 1997-12-01 | Traditional | PDF ↗ |
| K964407 | IMX CA 15-3 | Abbott Laboratories | 1997-11-10 | Traditional | PDF ↗ |
| K965141 | TRUQUANT BR RIA | Biomira USA, Inc. | 1997-10-31 | Traditional | PDF ↗ |
| K963926 | AXSYM CA 15-3 | Abbott Laboratories | 1997-09-15 | Traditional | PDF ↗ |
| K970695 | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) | Chiron Diagnostics Corp. | 1997-08-08 | Traditional | PDF ↗ |
| K971418 | CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER | Chiron Diagnostics Corp. | 1997-07-17 | Traditional | PDF ↗ |
| K963803 | CENTOCOR CA 15-3 RIA MODEL NO. 800-033 | Centocor, Inc. | 1997-05-23 | Traditional | PDF ↗ |
Product code MOI · Class II · Immunology. Data: openFDA.