FDA Product Code
FDA Product Code KLI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1700
510(k) Clearances — 86 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K160495 | VITROS® Automation Solutions | Ortho-Clinical Diagnostics, Inc. | 2016-10-18 | Traditional | PDF ↗ |
| K131515 | ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT | Alfa Wassermann | 2013-08-14 | Traditional | PDF ↗ |
| K103484 | GSP NEONATAL THYROXINE (T4) | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2011-04-22 | Traditional | PDF ↗ |
| K082638 | ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL | Siemens Healthcare Diagnostics, Inc. | 2009-02-26 | Traditional | PDF ↗ |
| K030860 | ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 | Monobind | 2003-08-22 | Traditional | PDF ↗ |
| K023369 | ACCESS TOTAL T4 ASSAY | Beckman Coulter, Inc. | 2002-12-09 | Traditional | PDF ↗ |
| K001603 | REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) | Repromedix Corp. | 2000-10-05 | Traditional | PDF ↗ |
| K000600 | SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS | Syva Co., Dade Behring, Inc. | 2000-03-27 | Traditional | PDF ↗ |
| K991432 | BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 | Biocheck, Inc. | 1999-06-02 | Traditional | PDF ↗ |
| K982298 | OPTICOAT T4 EIA KIT | Biotecx Laboratories, Inc. | 1999-02-03 | Traditional | PDF ↗ |
| K983440 | ABBOTT ARCHITECT TOTAL T4 | Abbott Laboratories | 1998-11-25 | Traditional | PDF ↗ |
| K981377 | ACE T4 REAGENT T4 CALIBRATORS | Schiapparelli Biosystems, Inc. | 1998-06-10 | Traditional | PDF ↗ |
| K972974 | ACCUWELL T4-EIA | Neometrics, Inc. | 1997-10-06 | Traditional | PDF ↗ |
| K971709 | TOTAL THROXINE MICROPLATE EIA(225-300) | Monobind | 1997-06-16 | Traditional | PDF ↗ |
| K971269 | DSL ACTIVE T4 EIA | Diagnostic Systems Laboratories, Inc. | 1997-05-22 | Traditional | PDF ↗ |
| K971203 | SYNCHRON SYSTEMS THYROXINE REAGENT | Beckman Instruments, Inc. | 1997-05-16 | Traditional | PDF ↗ |
| K964721 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-12-18 | Traditional | PDF ↗ |
| K951014 | ISOLAB'S T4 TEST KIT | Isolab, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K962211 | UBI MAGIWEL THYROXINE (T4) QUANTITATIVE | United Biotech, Inc. | 1996-07-08 | Traditional | PDF ↗ |
| K953837 | BIOCIRCUITS IOS T4 TEST CARTRIDGE | Biocircuits Corp. | 1995-11-20 | Traditional | PDF ↗ |
| K952751 | BIOCIRCUITS IOS T4/TU TEST CARTRIDGES | Biocircuits Corp. | 1995-11-20 | Traditional | PDF ↗ |
| K951321 | RADIAS NEONATAL T4 ENZYME IMMUNOASSAY | Bio-Rad | 1995-08-24 | Traditional | PDF ↗ |
| K950588 | T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 | Biomerica, Inc. | 1995-06-29 | Traditional | PDF ↗ |
| K946163 | RADIAS TOTAL T4 ENZYME IMMUNOASSAY | Bio-Rad | 1995-02-22 | Traditional | PDF ↗ |
| K944703 | THYROXINE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1994-12-09 | Traditional | PDF ↗ |
| K943019 | CEDIA T4 MAB ASSAY | Microgenics Corp. | 1994-10-20 | Traditional | PDF ↗ |
| K942575 | CEDIA T4 MAB ASSAY | Microgenics Corp. | 1994-07-28 | Traditional | PDF ↗ |
| K941042 | CEDIA T4 MAB ASSAY | Microgenics Corp. | 1994-04-26 | Traditional | PDF ↗ |
| K935880 | CEDIA T4 MAB ASSAY MODIFICATION | Microgenics Corp. | 1994-03-03 | Traditional | PDF ↗ |
| K932605 | COBAS (R) CORE T4 EIA | Roche Diagnostic Systems, Inc. | 1994-01-24 | Traditional | PDF ↗ |
| K926475 | ACCESS(R) THYROXINE ASSAY | Bio-Rad Laboratories, Inc. | 1993-06-15 | Traditional | PDF ↗ |
| K926393 | VIDAS THYROXINE (T4) ASSAY (T4) | Biomerieux Vitek, Inc. | 1993-05-13 | Traditional | PDF ↗ |
| K922433 | VISTA THYROXINE (T-4) ASSAY -- MODIFICATION | Syva Co. | 1992-09-18 | Traditional | PDF ↗ |
| K921904 | THYROXINE (FPIA) KIT | Tudor Laboratories, Inc. | 1992-06-24 | Traditional | PDF ↗ |
| K920712 | MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1992-03-27 | Traditional | PDF ↗ |
| K915194 | CEDIA T4 | Boehringer Mannheim Corp. | 1991-12-09 | Traditional | PDF ↗ |
| K912616 | TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES | Technicon Instruments Corp. | 1991-09-25 | Traditional | PDF ↗ |
| K911217 | SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) | Serono-Baker Diagnostics, Inc. | 1991-08-16 | Traditional | PDF ↗ |
| K910261 | IMMULITE(TM) TOTAL T4 | Cirrus Diagnostics, Inc. | 1991-04-16 | Traditional | PDF ↗ |
| K903095 | IL THYROXINE (T4) ASSAY SYSTEM | Instrumentation Laboratory CO | 1990-08-23 | Traditional | PDF ↗ |
| K897072 | NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR | Kallestad Diag, A Div. of Erbamont, Inc. | 1990-03-29 | Traditional | PDF ↗ |
| K897193 | OPUS T4 TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1990-03-19 | Traditional | PDF ↗ |
| K897144 | THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1990-03-15 | Traditional | PDF ↗ |
| K896982 | AIA-PACK T4 | Tosoh Corp. | 1990-03-09 | Traditional | PDF ↗ |
| K896865 | VITRO T4-EIA-XT | In Vitro Diagnostics, Inc. | 1990-01-30 | Traditional | PDF ↗ |
| K896329 | D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. | Photec Diagnostics, Inc. | 1989-12-12 | Traditional | PDF ↗ |
| K892853 | T4 CLASP-BEAD EIA KIT | Biotecx Laboratories, Inc. | 1989-05-22 | Traditional | PDF ↗ |
| K890831 | EMIT CONVENIENCE PACK: THYROXINE ASSAY | Syva Co. | 1989-04-14 | Traditional | PDF ↗ |
| K884260 | THYROXINE MICROASSAY | Diamedix Corp. | 1989-02-23 | Traditional | PDF ↗ |
| K885258 | ACA THYROXINE (T4 E) METHOD | The DU Pont Co. | 1989-02-17 | Traditional | PDF ↗ |
| K885141 | EMIT THYROXINE ASSAY | Syva Co. | 1989-02-17 | Traditional | PDF ↗ |
| K884700 | ANALYST THYROXINE (T4) ROTOR | The DU Pont Co. | 1989-01-27 | Traditional | PDF ↗ |
| K884634 | MODIFIED CEDIA TOTAL T4 ASSAY | Microgenics Corp. | 1988-12-09 | Traditional | PDF ↗ |
| K881357 | EMIT CONVENIENCE PACK: THYROXINE ASSAY | Syva Co. | 1988-05-27 | Traditional | PDF ↗ |
| K880620 | EMIT THYROXINE ASSAY | Syva Co. | 1988-03-24 | Traditional | PDF ↗ |
| K880662 | VISION(R) THYROXINE (T4) | Abbott Laboratories | 1988-03-16 | Traditional | PDF ↗ |
| K874866 | T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE | Serono Diagnostics, Inc. | 1988-02-11 | Traditional | PDF ↗ |
| K874603 | CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY) | Ciba Corning Diagnostics Corp. | 1987-12-18 | Traditional | PDF ↗ |
| K873976 | AMERLITE TT4 ASSAY (240/480/144 TEST KITS) | Amersham Corp. | 1987-11-05 | Traditional | PDF ↗ |
| K873518 | AFFINITY TOTAL THYROXINE IMMUNIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-10-29 | Traditional | PDF ↗ |
| K872192 | IMMUBEAD T4 ENZYME IMMUNOASSAY KIT | Immunotech Corp. | 1987-08-13 | Traditional | PDF ↗ |
| K862233 | CIBA CORNING PRISMA T4 LIPIA (LIPOSOME) | Ciba Corning Diagnostics Corp. | 1986-10-14 | Traditional | PDF ↗ |
| K854971 | V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT | V-Tech, Inc. | 1986-02-06 | Traditional | PDF ↗ |
| K852164 | CEDIA TOTAL T4 ASSAY | Microgenics Corp. | 1985-07-22 | Traditional | PDF ↗ |
| K841601 | TERUMO SENSIBEAD THYROXINE EIA KIT | Terumo Medical Corp. | 1984-05-22 | Traditional | PDF ↗ |
| K841576 | TECHNICON RA-1000 SYS T4-THYROXINE | Technicon Instruments Corp. | 1984-05-22 | Traditional | PDF ↗ |
| K840473 | VENTREZYME T4 IMMUNOASSAY T4 | Vxr, Inc. | 1984-04-04 | Traditional | PDF ↗ |
| K840241 | THYROXINE EMIA | Collaborative Research, Inc. | 1984-03-30 | Traditional | PDF ↗ |
| K834102 | RA-1000 SYS-T4(THYROXINE)SERUM ANAL | Technicon Instruments Corp. | 1984-03-15 | Traditional | PDF ↗ |
| K834210 | STRATUS TOTAL THYROXINE FLUOROMETRIC | American Dade | 1984-03-05 | Traditional | PDF ↗ |
| K830683 | TDX THYROXINE | Abbott Laboratories | 1983-04-06 | Traditional | PDF ↗ |
| K830769 | FEKAL CON-TRATE SYSTEM | Trend Scientific, Inc. | 1983-04-05 | Traditional | PDF ↗ |
| K830136 | PARAMOUNT THYROXINE ASSAY | Syva Co. | 1983-02-07 | Traditional | PDF ↗ |
| K823751 | SOPHEIA THYROXINE EIA KIT | Diagnostic Products Corp. | 1983-01-12 | Traditional | PDF ↗ |
| K823034 | SYVA ADVANCE THYROXINE ASSAY | Syva Co. | 1982-11-08 | Traditional | PDF ↗ |
| K820750 | ENZYMUNE-TEST T4 | Icl Scientific | 1982-04-06 | Traditional | PDF ↗ |
| K810586 | EMIT-TFG PRISMA THYROXINE ASSAY | Syva Co. | 1981-03-17 | Traditional | PDF ↗ |
| K802693 | OREIA-Q-TY, ENZYME IMMUNOASSAY | Organon, Inc. | 1980-12-10 | Traditional | PDF ↗ |
| K801475 | APPLICATION OF EMIT AED ASSAYS | Syva Co. | 1980-07-08 | Traditional | PDF ↗ |
| K801288 | EMIT AAII THYROXINE ASSAY | Syva Co. | 1980-06-30 | Traditional | PDF ↗ |
| K800384 | SMAC SYSTEM, T4 METHOD | Technicon Instruments Corp. | 1980-03-19 | Traditional | PDF ↗ |
| K790848 | A-GENT QUANTICHROM T4 11A | Abbott Laboratories | 1979-08-10 | Traditional | PDF ↗ |
| K790686 | EMIT CFA THYROXINE ASSAY | Syva Co. | 1979-05-25 | Traditional | PDF ↗ |
| K782085 | EMIT THYROXINE ASSAY | Syva Co. | 1979-02-01 | Traditional | PDF ↗ |
| K781828 | COMPUTER, 3500, GILFORD SYSTEM | Syva Co. | 1978-12-04 | Traditional | PDF ↗ |
| K770070 | ENIT ABA THYROXINE ASSAY | Syva Co. | 1977-01-21 | Traditional | PDF ↗ |
Product code KLI · Class II · Clinical Chemistry. Data: openFDA.