Product code CDP
- Device name
- Radioimmunoassay, Total Triiodothyronine
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1710
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K001607 | REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) | Repromedix Corp. | 2000-10-05 |
| K991692 | CHIRON DIAGNOSTICS ACS: 180 FT3 | Chiron Diagnostics Corp. | 1999-06-18 |
| K991311 | TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 | Biocheck, Inc. | 1999-06-02 |
| K991252 | AIA-PACK FT3 ASSAY | Tosoh Medics, Inc. | 1999-05-11 |
| K981824 | OPTICOAT T3 EIA KIT | Biotecx Laboratories, Inc. | 1998-12-22 |
| K983434 | ABBOTT ARCHITECT TOTAL T3 | Abbott Laboratories | 1998-11-20 |
| K983439 | ABBOTT ARCHITECT FREE T3 | Abbott Laboratories | 1998-11-20 |
| K974027 | AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK | Alfa Biotech (Uk) , Ltd. | 1998-02-02 |
| K974634 | IMMULITE FREE T3 | Diagnostic Products Corp. | 1998-01-02 |
| K973966 | ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | Beckman Instruments, Inc. | 1997-10-31 |
| K971779 | TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA | Monobind | 1997-06-16 |
| K971270 | DSL ACTIVE T3 EIA | Diagnostic Systems Laboratories, Inc. | 1997-05-22 |
| K965058 | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT | Nichols Institute Diagnostics | 1997-03-11 |
| K970016 | VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-01-30 |
| K963127 | ELECSYS FT3 | Boehringer Mannheim Corp. | 1996-12-16 |
| K962760 | ENZYMUN-TEST FT3 | Boehringer Mannheim Corp. | 1996-11-29 |
| K964310 | VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-11-27 |
| K963687 | AIA-PACK FT3 ASSAY | Tosoh Medics, Inc. | 1996-11-08 |
| K963833 | IMX FREE TRIIODOTHYRONINE (FREE T3) | Abbott Laboratories | 1996-10-30 |
| K963827 | AXSYM FREE TRIIODOTHYRONINE (FREE T3) | Abbott Laboratories | 1996-10-30 |
| K962508 | ELECSYS T3 | Boehringer Mannheim Corp. | 1996-08-15 |
| K962355 | FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | 1996-07-12 |
| K961236 | UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE | United Biotech, Inc. | 1996-05-30 |
| K960913 | ACCESS FREE T3 ASSAY | Bio-Rad Laboratories, Inc. | 1996-03-29 |
| K960412 | T-3 MICROWELL EIA MODEL 7013 | Biomerica, Inc. | 1996-03-19 |
| K960550 | ACTIVE T3 RIA | Diagnostic Systems Laboratories, Inc. | 1996-03-06 |
| K955435 | ACCESS TOTAL T3 ASSAY (MODIFICATION) | Bio-Rad Laboratories, Inc. | 1996-01-24 |
| K952557 | TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS | Sigma Diagnostics, Inc. | 1996-01-24 |
| K953160 | OPUS T3 | Behring Diagnostics, Inc. | 1995-08-24 |
| K944808 | IMX T3 ASSAY | Organon Teknika Corp. | 1994-12-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850054026446 | AccuDiag™ T3 ELISA Kit | Diagnostic Automation, Inc. | 2026-03-02 |
| 14562185395447 | CL AIA-PACK T3 TEST CUP | TOSOH CORPORATION | 2025-09-01 |
| 24562185395444 | CL AIA-PACK T3 TEST CUP | TOSOH CORPORATION | 2025-09-01 |
| 04048474053562 | T3 free | DRG Instruments Gesellschaft mit beschränkter Haftung | 2024-09-23 |
| 00840239023858 | Free Triiodothyronine (fT3) ELISA | DRG International Inc | 2024-09-23 |
| 04048474038019 | Free T3 ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2024-09-23 |
| 04048474023855 | Free Triiodothyronine (fT3) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2024-09-23 |
| 00840239053565 | T3 free | DRG International Inc | 2024-09-23 |
| 00840239038012 | Free T3 ELISA | DRG International Inc | 2024-09-23 |
| 04048474056976 | T-3 | DRG Instruments Gesellschaft mit beschränkter Haftung | 2024-08-13 |
| 00840239056979 | T-3 | DRG International Inc | 2024-08-13 |
| B24220TT3HUE011 | Total Triiodothyronine (Total T3) ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2024-07-22 |
| 04049016139232 | Free Triiodothyronine (FT3) ELISA | EUROIMMUN Medizinische Labordiagnostika AG | 2022-12-08 |
| 00630414293769 | Atellica IM T3 | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00630414293677 | Atellica IM FT3 | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 04560189211223 | AIA-PACK TT3 CALIBRATOR SET | TOSOH CORPORATION | 2019-07-25 |
| 14560189210339 | ST AIA-PACK TT3 | TOSOH CORPORATION | 2019-07-25 |
| 14560189211190 | AIA-PACK FT3 Calibrator Set | TOSOH CORPORATION | 2019-07-24 |
| 14560189210285 | ST AIA-PACK FT3 | TOSOH CORPORATION | 2019-07-24 |
| 04560189211216 | AIA-PACK TT3 SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | 2019-07-24 |
| 04560189211193 | AIA-PACK FT3 Calibrator Set | TOSOH CORPORATION | 2019-07-24 |
| 04015630939794 | Elecsys T3 | Roche Diagnostics GmbH | 2017-04-14 |
| 04015630939718 | Elecsys FT3 III | Roche Diagnostics GmbH | 2017-04-14 |
| 04015630934171 | Elecsys FT3 III | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630899937 | Elecsys T3 | Roche Diagnostics GmbH | 2016-09-20 |
| 00380740105945 | ARCHITECT | ABBOTT IRELAND | 2016-09-09 |
| 00380740014346 | ARCHITECT | ABBOTT IRELAND | 2016-09-09 |
| 00380740014308 | ARCHITECT | ABBOTT IRELAND | 2016-09-09 |
| 00380740014285 | ARCHITECT | ABBOTT IRELAND | 2016-09-09 |
| 00380740014261 | ARCHITECT | ABBOTT IRELAND | 2016-09-09 |