CDP — Radioimmunoassay, Total Triiodothyronine Class II
FDA product code CDP covers "Radioimmunoassay, Total Triiodothyronine", a Class II medical device regulated under 21 CFR 862.1710. 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
- CDP
- Device Class
- Class II
- Regulation Number
- 862.1710
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K001607 | repromedix | REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) | October 5, 2000 |
| K991692 | chiron diagnostics | CHIRON DIAGNOSTICS ACS: 180 FT3 | June 18, 1999 |
| K991311 | biocheck | TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 | June 2, 1999 |
| K991252 | tosoh medics | AIA-PACK FT3 ASSAY | May 11, 1999 |
| K981824 | biotecx laboratories | OPTICOAT T3 EIA KIT | December 22, 1998 |
| K983439 | abbott laboratories | ABBOTT ARCHITECT FREE T3 | November 20, 1998 |
| K983434 | abbott laboratories | ABBOTT ARCHITECT TOTAL T3 | November 20, 1998 |
| K974027 | alfa biotech (uk) | AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK | February 2, 1998 |
| K974634 | diagnostic products | IMMULITE FREE T3 | January 2, 1998 |
| K973966 | beckman instruments | ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | October 31, 1997 |
| K971779 | monobind | TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA | June 16, 1997 |
| K971270 | diagnostic systems laboratories | DSL ACTIVE T3 EIA | May 22, 1997 |
| K965058 | nichols institute diagnostics | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT | March 11, 1997 |
| K970016 | johnson and johnson clinical diagnostics | VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBR | January 30, 1997 |
| K963127 | boehringer mannheim | ELECSYS FT3 | December 16, 1996 |
| K962760 | boehringer mannheim | ENZYMUN-TEST FT3 | November 29, 1996 |
| K964310 | johnson and johnson clinical diagnostics | VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CA | November 27, 1996 |
| K963687 | tosoh medics | AIA-PACK FT3 ASSAY | November 8, 1996 |
| K963833 | abbott laboratories | IMX FREE TRIIODOTHYRONINE (FREE T3) | October 30, 1996 |
| K963827 | abbott laboratories | AXSYM FREE TRIIODOTHYRONINE (FREE T3) | October 30, 1996 |