Panels › Clinical Chemistry › Product code KLI · Class 2
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Regulation 862.1700
0510(k)s in 12 months (86 all time)
1recalls in 12 months (12 all time)
10recalls that name a 510(k)
Top companies in KLI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 18, 2016 | K160495 | VITROS® Automation Solutions Ortho-Clinical Diagnostics, Inc. | KLI |
| Aug 14, 2013 | K131515 | ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT Alfa Wassermann | KLI |
| Apr 22, 2011 | K103484 | GSP NEONATAL THYROXINE (T4) Wallac Oy, A Subsidiary of Perkinelmer, Inc. | KLI |
| Feb 26, 2009 | K082638 | ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL Siemens Healthcare Diagnostics, Inc. | KLI |
| Aug 22, 2003 | K030860 | ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 Monobind | KLI |
| Dec 9, 2002 | K023369 | ACCESS TOTAL T4 ASSAY Beckman Coulter, Inc. | KLI |
| Oct 5, 2000 | K001603 | REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) Repromedix Corp. | KLI |
| Mar 27, 2000 | K000600 | SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS Syva Co., Dade Behring, Inc. | KLI |
| Jun 2, 1999 | K991432 | BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 Biocheck, Inc. | KLI |
| Feb 3, 1999 | K982298 | OPTICOAT T4 EIA KIT Biotecx Laboratories, Inc. | KLI |
| Nov 25, 1998 | K983440 | ABBOTT ARCHITECT TOTAL T4 Abbott Laboratories | KLI |
| Jun 10, 1998 | K981377 | ACE T4 REAGENT T4 CALIBRATORS Schiapparelli Biosystems, Inc. | KLI |
| Oct 6, 1997 | K972974 | ACCUWELL T4-EIA Neometrics, Inc. | KLI |
| Jun 16, 1997 | K971709 | TOTAL THROXINE MICROPLATE EIA(225-300) Monobind | KLI |
| May 22, 1997 | K971269 | DSL ACTIVE T4 EIA Diagnostic Systems Laboratories, Inc. | KLI |
| May 16, 1997 | K971203 | SYNCHRON SYSTEMS THYROXINE REAGENT Beckman Instruments, Inc. | KLI |
| Dec 18, 1996 | K964721 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) Johnson & Johnson Clinical Diagnostics, Inc. | KLI |
| Oct 18, 1996 | K951014 | ISOLAB'S T4 TEST KIT Isolab, Inc. | KLI |
| Jul 8, 1996 | K962211 | UBI MAGIWEL THYROXINE (T4) QUANTITATIVE United Biotech, Inc. | KLI |
| Nov 20, 1995 | K953837 | BIOCIRCUITS IOS T4 TEST CARTRIDGE Biocircuits Corp. | KLI |
| Nov 20, 1995 | K952751 | BIOCIRCUITS IOS T4/TU TEST CARTRIDGES Biocircuits Corp. | KLI |
| Aug 24, 1995 | K951321 | RADIAS NEONATAL T4 ENZYME IMMUNOASSAY Bio-Rad | KLI |
| Jun 29, 1995 | K950588 | T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 Biomerica, Inc. | KLI |
| Feb 22, 1995 | K946163 | RADIAS TOTAL T4 ENZYME IMMUNOASSAY Bio-Rad | KLI |
| Dec 9, 1994 | K944703 | THYROXINE ENZYME IMMUNOASSAY Diagnostic Reagents, Inc. | KLI |
| Oct 20, 1994 | K943019 | CEDIA T4 MAB ASSAY Microgenics Corp. | KLI |
| Jul 28, 1994 | K942575 | CEDIA T4 MAB ASSAY Microgenics Corp. | KLI |
| Apr 26, 1994 | K941042 | CEDIA T4 MAB ASSAY Microgenics Corp. | KLI |
| Mar 3, 1994 | K935880 | CEDIA T4 MAB ASSAY MODIFICATION Microgenics Corp. | KLI |
| Jan 24, 1994 | K932605 | COBAS (R) CORE T4 EIA Roche Diagnostic Systems, Inc. | KLI |
| Jun 15, 1993 | K926475 | ACCESS(R) THYROXINE ASSAY Bio-Rad Laboratories, Inc. | KLI |
| May 13, 1993 | K926393 | VIDAS THYROXINE (T4) ASSAY (T4) Biomerieux Vitek, Inc. | KLI |
| Sep 18, 1992 | K922433 | VISTA THYROXINE (T-4) ASSAY -- MODIFICATION Syva Co. | KLI |
| Jun 24, 1992 | K921904 | THYROXINE (FPIA) KIT Tudor Laboratories, Inc. | KLI |
| Mar 27, 1992 | K920712 | MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | KLI |
| Dec 9, 1991 | K915194 | CEDIA T4 Boehringer Mannheim Corp. | KLI |
| Sep 25, 1991 | K912616 | TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES Technicon Instruments Corp. | KLI |
| Aug 16, 1991 | K911217 | SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) Serono-Baker Diagnostics, Inc. | KLI |
| Apr 16, 1991 | K910261 | IMMULITE(TM) TOTAL T4 Cirrus Diagnostics, Inc. | KLI |
| Aug 23, 1990 | K903095 | IL THYROXINE (T4) ASSAY SYSTEM Instrumentation Laboratory CO | KLI |
| Mar 29, 1990 | K897072 | NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR Kallestad Diag, A Div. of Erbamont, Inc. | KLI |
| Mar 19, 1990 | K897193 | OPUS T4 TEST SYSTEM Pb Diagnostic Systems, Inc. | KLI |
| Mar 15, 1990 | K897144 | THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | KLI |
| Mar 9, 1990 | K896982 | AIA-PACK T4 Tosoh Corp. | KLI |
| Jan 30, 1990 | K896865 | VITRO T4-EIA-XT In Vitro Diagnostics, Inc. | KLI |
| Dec 12, 1989 | K896329 | D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. Photec Diagnostics, Inc. | KLI |
| May 22, 1989 | K892853 | T4 CLASP-BEAD EIA KIT Biotecx Laboratories, Inc. | KLI |
| Apr 14, 1989 | K890831 | EMIT CONVENIENCE PACK: THYROXINE ASSAY Syva Co. | KLI |
| Feb 23, 1989 | K884260 | THYROXINE MICROASSAY Diamedix Corp. | KLI |
| Feb 17, 1989 | K885258 | ACA THYROXINE (T4 E) METHOD The DU Pont Co. | KLI |
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