CDP · Radioimmunoassay, Total Triiodothyronine
Clinical Chemistry · 21 CFR 862.1710 · Class 2
Overview
| Product Code | CDP |
|---|---|
| Device Name | Radioimmunoassay, Total Triiodothyronine |
| Regulation | 21 CFR 862.1710 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.
Classification Rationale
Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (20 of 144)
Showing 20 most recent of 144 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K001607 | REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) | Repromedix Corp. | Oct 5, 2000 | SESE |
| K991692 | CHIRON DIAGNOSTICS ACS: 180 FT3 | Chiron Diagnostics Corp. | Jun 18, 1999 | SESE |
| K991311 | TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 | Biocheck, Inc. | Jun 2, 1999 | SESE |
| K991252 | AIA-PACK FT3 ASSAY | Tosoh Medics, Inc. | May 11, 1999 | SESE |
| K981824 | OPTICOAT T3 EIA KIT | Biotecx Laboratories, Inc. | Dec 22, 1998 | SESE |
| K983439 | ABBOTT ARCHITECT FREE T3 | Abbott Laboratories | Nov 20, 1998 | SESE |
| K983434 | ABBOTT ARCHITECT TOTAL T3 | Abbott Laboratories | Nov 20, 1998 | SESE |
| K974027 | AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK | Alfa Biotech (Uk) , Ltd. | Feb 2, 1998 | SESE |
| K974634 | IMMULITE FREE T3 | Diagnostic Products Corp. | Jan 2, 1998 | SESE |
| K973966 | ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | Beckman Instruments, Inc. | Oct 31, 1997 | SESE |
| K971779 | TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA | Monobind | Jun 16, 1997 | SESE |
| K971270 | DSL ACTIVE T3 EIA | Diagnostic Systems Laboratories, Inc. | May 22, 1997 | SESE |
| K965058 | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT | Nichols Institute Diagnostics | Mar 11, 1997 | SESE |
| K970016 | VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) | Johnson & Johnson Clinical Diagnostics, Inc. | Jan 30, 1997 | SESE |
| K963127 | ELECSYS FT3 | Boehringer Mannheim Corp. | Dec 16, 1996 | SESE |
| K962760 | ENZYMUN-TEST FT3 | Boehringer Mannheim Corp. | Nov 29, 1996 | SESE |
| K964310 | VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) | Johnson & Johnson Clinical Diagnostics, Inc. | Nov 27, 1996 | SESE |
| K963687 | AIA-PACK FT3 ASSAY | Tosoh Medics, Inc. | Nov 8, 1996 | SESE |
| K963833 | IMX FREE TRIIODOTHYRONINE (FREE T3) | Abbott Laboratories | Oct 30, 1996 | SESE |
| K963827 | AXSYM FREE TRIIODOTHYRONINE (FREE T3) | Abbott Laboratories | Oct 30, 1996 | SESE |
Top Applicants
- Abbott Laboratories — 13 clearances
- Amersham Corp. — 7 clearances
- Diagnostic Products Corp. — 6 clearances
- Boehringer Mannheim Corp. — 4 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 3 clearances
