CEC — Radioimmunoassay, Free Thyroxine Class II
FDA product code CEC covers "Radioimmunoassay, Free Thyroxine", a Class II medical device regulated under 21 CFR 862.1695. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CEC
- Device Class
- Class II
- Regulation Number
- 862.1695
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240273 | beckman coulter | Access Free T4 | March 6, 2024 |
| K220456 | roche diagnostics | Elecsys FT4 IV | April 7, 2023 |
| K182423 | shenzhen new industries biomedical engineering co | MAGLUMI 2000 FT4 | October 4, 2018 |
| K181233 | roche diagnostics | Elecsys FT4 III | September 18, 2018 |
| K173122 | abbott laboratories | Abbott Architect Free T4 | October 27, 2017 |
| K152422 | nanoentek usa | FREND Free T4 Test System | February 17, 2016 |
| K132058 | biomerieux | VIDAS FT4 | June 8, 2015 |
| K140859 | siemens healthcare diagnostics | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYR | November 26, 2014 |
| K140842 | siemens healthcare diagnostics | DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYRO | November 26, 2014 |
| K131244 | roche diagnostics | ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET | January 27, 2014 |
| K132249 | siemens healthcare diagnostics | ADVIA CENTAUR FT4, ADVIA CENTAUR T4 | September 13, 2013 |
| K121951 | diasorin | LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL | April 4, 2013 |
| K123379 | abbott laboratories | ABBOTT ARCHITECT FREE T4 | November 27, 2012 |
| K083373 | siemens healthcare diagnostics | IMMULITE 2000 FREE T4 | February 2, 2009 |
| K080167 | siemens healthcare diagnostics | ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS | August 8, 2008 |
| K073604 | dade behring | DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CAR | March 13, 2008 |
| K070708 | olympus life and material science europa gmbh (irish | OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR2 | August 21, 2007 |
| K053531 | dade behring | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR | March 3, 2006 |
| K030329 | qualigen | FASTPACK FREE T4 IMMUNOASSAY | July 3, 2003 |
| K020548 | monobind | FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 | April 5, 2002 |