MOI — System, Test, Immunological, Antigen, Tumor Class II
FDA Device Classification
Classification Details
- Product Code
- MOI
- Device Class
- Class II
- Regulation Number
- 866.6010
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K240403 | beckman coulter | Access BR Monitor | May 9, 2024 |
| K233946 | siemens healthcare diagnostics products | IMMULITE® 2000 BR-MA | March 13, 2024 |
| K192524 | fujirebio diagnostics | Lumipulse G CA15-3 | September 4, 2020 |
| K193489 | siemens healthcare diagnostics | ADVIA Centaur BR | February 13, 2020 |
| K192777 | siemens healthcare diagnostics | ADVIA Centaur CA 15-3 assay | November 22, 2019 |
| K181492 | roche diagnostics | Elecsys CA 15-3 II | June 22, 2018 |
| K171605 | roche diagnostics | Elecsys CA 15-3 II | February 20, 2018 |
| K100344 | siemens healthcare diagnostics | DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALI | April 18, 2011 |
| K072612 | beckman coulter | ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 3876 | October 26, 2007 |
| K042732 | fujirebio diagnostics | ARCHITECT CA 15-3 ASSAY | December 22, 2004 |
| K033036 | beckman coulter | BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 3 | February 3, 2004 |
| K022178 | bayer diagnostics | CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | November 12, 2002 |
| K013984 | diagnostic products | IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR | March 28, 2002 |
| K012357 | bayer diagnostics | CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM | February 28, 2002 |
| K010796 | tosoh medics | AIA-PACK BRCA, ST AIA PACK BRCA | August 16, 2001 |
| K010588 | roche diagnostics | ELECSYSCA 15-3 II ASSAY | March 28, 2001 |
| K001468 | roche diagnostics | ELECSYS CA 15-3 TEST SYSTEM | October 23, 2000 |
| K983690 | ortho-clinical diagnostics | VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRO | February 2, 1999 |
| K982680 | chiron diagnostics | CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY | October 15, 1998 |
| K981698 | chiron | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER AN | July 10, 1998 |