MOI — System, Test, Immunological, Antigen, Tumor Class II
FDA product code MOI covers "System, Test, Immunological, Antigen, Tumor", a Class II medical device regulated under 21 CFR 866.6010. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |