Product code KLI
- Device name
- Enzyme Immunoassay, Non-Radiolabeled, 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 |
|---|---|---|---|
| K160495 | VITROS® Automation Solutions | Ortho-Clinical Diagnostics, Inc. | 2016-10-18 |
| K131515 | ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT | Alfa Wassermann | 2013-08-14 |
| K103484 | GSP NEONATAL THYROXINE (T4) | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2011-04-22 |
| K082638 | ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL | Siemens Healthcare Diagnostics, Inc. | 2009-02-26 |
| K030860 | ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 | Monobind | 2003-08-22 |
| K023369 | ACCESS TOTAL T4 ASSAY | Beckman Coulter, Inc. | 2002-12-09 |
| K001603 | REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) | Repromedix Corp. | 2000-10-05 |
| K000600 | SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS | Syva Co., Dade Behring, Inc. | 2000-03-27 |
| K991432 | BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 | Biocheck, Inc. | 1999-06-02 |
| K982298 | OPTICOAT T4 EIA KIT | Biotecx Laboratories, Inc. | 1999-02-03 |
| K983440 | ABBOTT ARCHITECT TOTAL T4 | Abbott Laboratories | 1998-11-25 |
| K981377 | ACE T4 REAGENT T4 CALIBRATORS | Schiapparelli Biosystems, Inc. | 1998-06-10 |
| K972974 | ACCUWELL T4-EIA | Neometrics, Inc. | 1997-10-06 |
| K971709 | TOTAL THROXINE MICROPLATE EIA(225-300) | Monobind | 1997-06-16 |
| K971269 | DSL ACTIVE T4 EIA | Diagnostic Systems Laboratories, Inc. | 1997-05-22 |
| K971203 | SYNCHRON SYSTEMS THYROXINE REAGENT | Beckman Instruments, Inc. | 1997-05-16 |
| K964721 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-12-18 |
| K951014 | ISOLAB'S T4 TEST KIT | Isolab, Inc. | 1996-10-18 |
| K962211 | UBI MAGIWEL THYROXINE (T4) QUANTITATIVE | United Biotech, Inc. | 1996-07-08 |
| K953837 | BIOCIRCUITS IOS T4 TEST CARTRIDGE | Biocircuits Corp. | 1995-11-20 |
| K952751 | BIOCIRCUITS IOS T4/TU TEST CARTRIDGES | Biocircuits Corp. | 1995-11-20 |
| K951321 | RADIAS NEONATAL T4 ENZYME IMMUNOASSAY | Bio-Rad | 1995-08-24 |
| K950588 | T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 | Biomerica, Inc. | 1995-06-29 |
| K946163 | RADIAS TOTAL T4 ENZYME IMMUNOASSAY | Bio-Rad | 1995-02-22 |
| K944703 | THYROXINE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1994-12-09 |
| K943019 | CEDIA T4 MAB ASSAY | Microgenics Corp. | 1994-10-20 |
| K942575 | CEDIA T4 MAB ASSAY | Microgenics Corp. | 1994-07-28 |
| K941042 | CEDIA T4 MAB ASSAY | Microgenics Corp. | 1994-04-26 |
| K935880 | CEDIA T4 MAB ASSAY MODIFICATION | Microgenics Corp. | 1994-03-03 |
| K932605 | COBAS (R) CORE T4 EIA | Roche Diagnostic Systems, Inc. | 1994-01-24 |
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| 00850049545983 | QMedix™ | Diagnostic Automation, Inc. | 2024-02-02 |
| 04048474052794 | Total Thyroxine (tT4) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 04048474041095 | Free Thyroxine (fT4) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-31 |
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| 00840239052797 | Total Thyroxine (tT4) ELISA | DRG International Inc | 2023-08-25 |
| 00894175000893 | AccuDiag ™ | Diagnostic Automation, Inc. | 2023-06-14 |
| 06925912718512 | iFlash-T4 | Shenzhen YHLO Biotech Co., Ltd. | 2022-10-26 |
| 00725609000649 | SPOTCHECK | ASTORIA-PACIFIC, INC. | 2020-12-17 |
| 00850392007077 | BioCheck T4 EIA Test Kit | BIOCHECK, INC. | 2019-10-08 |
| 00840239041098 | Free Thyroxine (fT4) ELISA | DRG International Inc | 2019-06-10 |
| 00840239017819 | Total Thyroxine (T4) ELISA | DRG International Inc | 2019-03-20 |
| B24225TT4HUE010 | Total Thyroxine ELISA (Total T4 ELISA) | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2017-08-03 |
| 00842768005626 | Dimension® Flex® reagent cartridge T4 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04560189211797 | AIA-PACK T4 SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | 2016-09-24 |
| 14560189210803 | ST AIA-PACK T4 | TOSOH CORPORATION | 2016-09-24 |
| 04560189211803 | AIA-PACK T4 CALIBRATOR SET | TOSOH CORPORATION | 2016-09-24 |
| 00842768015434 | Dimension Vista® Flex® reagent cartridge T4 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04015630916016 | Total T4 Thyroxine) | Roche Diagnostics GmbH | 2016-09-20 |
| 15099590225742 | Access Total T4 | Beckman Coulter, Inc. | 2016-09-09 |
| 00380740014414 | ARCHITECT | ABBOTT IRELAND | 2016-09-09 |
| 00380740129491 | ARCHITECT | ABBOTT IRELAND | 2016-09-09 |
| 00380740105952 | ARCHITECT | ABBOTT IRELAND | 2016-09-09 |
| 00380740014438 | ARCHITECT | ABBOTT IRELAND | 2016-09-09 |
| 00380740014407 | ARCHITECT | ABBOTT IRELAND | 2016-09-09 |
| 03573026156916 | VIDAS® T4 | BIOMERIEUX SA | 2016-08-31 |
| 10758750005147 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-10 |
| 06438147312139 | GSP Neonatal Thyroxine (T4) kit | Wallac Oy | 2016-01-12 |