510(k) K181492
- Device
- Elecsys CA 15-3 II
- Applicant
- Roche Diagnostics
- 510(k) number
- K181492
- Product code
- MOI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-06-22
- Date received
- 2018-06-06
- Regulation
- 866.6010
- Classification name
- System, Test, Immunological, Antigen, Tumor
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Adennis Cora
- Address
- 9115 Hague Rd. P.O. Box 50416 Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 3006198300
- 3005333358
- 2432235
- 3012963943
- 2250051
- 3002809144
- 9612316
- 2020726
- 1036362
- 2517506
- 2521625
- 2122870
- 8031673
- 3011989923
- 3002637618
- 3002642396
- 8020888
- 1219913
- 3005529799
- 3007111389
- 9610126
- 1319681
- 3000308930
- 3002806944
- 2032839
Source Documents#
Other 510(k) Records For Product Code MOI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240403 | Access BR Monitor | Beckman Coulter, Inc. | 2024-05-09 |
| K233946 | IMMULITE® 2000 BR-MA | Siemens Healthcare Diagnostics Products, Ltd. | 2024-03-13 |
| K192524 | Lumipulse G CA15-3 | Fujirebio Diagnostics,Inc. | 2020-09-04 |
| K193489 | ADVIA Centaur BR | Siemens Healthcare Diagnostics, Inc. | 2020-02-13 |
| K192777 | ADVIA Centaur CA 15-3 assay | Siemens Healthcare Diagnostics, Inc. | 2019-11-22 |
| K171605 | Elecsys CA 15-3 II | Roche Diagnostics | 2018-02-20 |
| 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 |
| K072612 | ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 | Beckman Coulter, Inc. | 2007-10-26 |
| K042732 | ARCHITECT CA 15-3 ASSAY | Fujirebio Diagnostics,Inc. | 2004-12-22 |
| K033036 | BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 | Beckman Coulter, Inc. | 2004-02-03 |
| K022178 | CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-11-12 |
| K013984 | IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR | Diagnostic Products Corp. | 2002-03-28 |
| K012357 | CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM | Bayer Diagnostics Corp. | 2002-02-28 |
| K010796 | AIA-PACK BRCA, ST AIA PACK BRCA | Tosoh Medics, Inc. | 2001-08-16 |
| K010588 | ELECSYSCA 15-3 II ASSAY | Roche Diagnostics Corp. | 2001-03-28 |
Legacy Summary#
summary
FDA Review#
Decision Summary