CEC — Radioimmunoassay, Free Thyroxine Class II
FDA Device Classification
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 |
| K140842 | siemens healthcare diagnostics | DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYRO | November 26, 2014 |
| K140859 | siemens healthcare diagnostics | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYR | 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 |