CDP — Radioimmunoassay, Total Triiodothyronine Class II
FDA Device Classification
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 |
| K983434 | abbott laboratories | ABBOTT ARCHITECT TOTAL T3 | November 20, 1998 |
| K983439 | abbott laboratories | ABBOTT ARCHITECT FREE 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 |