Product code CDX
- Device name
- Radioimmunoassay, Total Thyroxine
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1700
- 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 |
|---|---|---|---|
| K961490 | ELECSYS T4 ASSAY | Boehringer Mannheim Corp. | 1996-06-13 |
| K954312 | ACTIVE THYROXINE RIA | Diagnostic Systems Laboratories, Inc. | 1995-10-07 |
| K943416 | DELFIA NEONATAL THYROXINE KIT | Wallac OY | 1995-03-10 |
| K934384 | AXSYM(TM) TOTAL T4 | Abbott Laboratories | 1994-06-21 |
| K932980 | TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 | Sigma Diagnostics, Inc. | 1993-10-18 |
| K933426 | STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO | Baxter Diagnostics, Inc. | 1993-08-26 |
| K931295 | IQ TT4 ASSAY | Becton Dickinson Advanced Diagnostics | 1993-07-20 |
| K926563 | AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT | Bio-Chem Laboratory Systems, Inc. | 1993-03-18 |
| K925110 | ABBOTT IMX T4 | Abbott Laboratories | 1993-01-26 |
| K925109 | ABBOTT TDX/TDXFLX TT4 | Abbott Laboratories | 1993-01-04 |
| K922945 | TECHNICON DAX SYSTEM THYROXINE (T4) METHOD | Heraeus Kulzer, Inc. | 1992-10-14 |
| K921935 | THYROXINE (T4) COATED TUBE RIA | Monobind | 1992-07-07 |
| K920766 | T4 EIA BEAD ASSAY | Tech-Co, Inc. | 1992-04-17 |
| K915235 | CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT | Incstar Corp. | 1992-01-28 |
| K912541 | MILENIA TOTAL T4, CATALOG: MKT41,5 | Diagnostic Products Corp. | 1991-08-12 |
| K911985 | LUMATAG T4 CHEMILUMINESCENCE ASSAY | London Diagnostics, Inc. | 1991-08-02 |
| K904816 | THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-01-17 |
| K905532 | CIBA CORNING ACS T4 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1991-01-15 |
| K902922 | MICROZYME T4 ENZYME IMMUNOASSAY KIT | Immunotech Corp. | 1990-07-27 |
| K901475 | CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4 | Baxter Healthcare Corp | 1990-06-20 |
| K901939 | NEOCOAT T4 | Neometrics, Inc. | 1990-05-31 |
| K894575 | TECHNICON RA SYSTEM THYROXINE T4 METHOD | Technicon Instruments Corp. | 1989-10-04 |
| K883559 | DELFIA THYROXINE (T4) KIT | Pharmacia, Inc. | 1988-12-14 |
| K874623 | FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101 | Cyberfluor, Inc. | 1988-02-16 |
| K875081 | IMMPULSE T4 ASSAY REAGENTS | Sclavo, Inc. | 1988-02-11 |
| K872286 | CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1987-07-21 |
| K871303 | DELFIA(TM) THYROXINE (T4) KIT | Lkb Instruments, Inc. | 1987-06-17 |
| K871008 | MICROMEDIC NEONATAL T4 KIT | Micromedic Systems | 1987-05-26 |
| K870965 | CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1987-05-14 |
| K870573 | T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT | Cambridge Medical Technology | 1987-04-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850054026484 | QMedix™ | Diagnostic Automation, Inc. | 2024-01-31 |
| 04048474045680 | T-4 Total ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-31 |
| 00840239045591 | Mycoplasma hominis IgG ELISA | DRG International Inc | 2023-08-25 |
| 00840239045683 | T-4 Total ELISA | DRG International Inc | 2023-08-25 |
| 06925912718512 | iFlash-T4 | Shenzhen YHLO Biotech Co., Ltd. | 2022-10-26 |
| 07613336171660 | Elecsys T4 | Roche Diagnostics GmbH | 2021-08-13 |
| 07613336171677 | Elecsys T4 | Roche Diagnostics GmbH | 2021-08-13 |
| 00816870021676 | T4 AccuBind ELISA Test System - 480 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021249 | N-T4 AccuBind ELISA Test System - 960 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021683 | T4 AccuBind ELISA Test System - 960 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021690 | T4 SBS AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021706 | T4 SBS AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870023090 | T4 AccuLite CLIA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870023106 | Monobind AccuLite T4 CLIA Kit - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870023113 | T4 AccuLite CLIA Test System - 480 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870023120 | T4 AccuLite CLIA Test System - 960 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870023137 | T4 SBS AccuLite CLIA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021669 | T4 AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021652 | T4 AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021256 | N-T4 AccuBind ELISA Test System - 1920 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021232 | N-T4 AccuBind ELISA Test System - 480 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021225 | N-T4 AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021218 | N-T4 AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870023144 | T4 SBS AccuLite CLIA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 04015630939800 | Elecsys T4 | Roche Diagnostics GmbH | 2017-04-21 |
| 04015630912728 | Elecsys T4 Assay | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630912711 | Elecsys CalSet T4 | Roche Diagnostics GmbH | 2016-09-20 |
| 06438147009251 | DELFIA Neonatal Thyroxine (T4) kit | Wallac Oy | 2016-02-02 |
| 06438147009589 | AutoDELFIA Neonatal Thyroxine (T4) kit | Wallac Oy | 2016-02-02 |
| 06438147179602 | AutoDELFIA Neonatal Thyroxine (T4) kit | Wallac Oy | 2016-02-02 |