Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KLI — Predicate Candidate Screening
86 FDA 510(k) clearances under this product code; the 50 most recent screened below.
58 daysmedian FDA review time
155 days90th percentile
86clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160495 | VITROS® Automation Solutions | Ortho-Clinical Diagnostics, Inc. | 2016-10-18 | 239 | 0 |
| K131515 | ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT | Alfa Wassermann | 2013-08-14 | 78 | 0 |
| K103484 | GSP NEONATAL THYROXINE (T4) | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2011-04-22 | 147 | 0 |
| K082638 | ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL | Siemens Healthcare Diagnostics, Inc. | 2009-02-26 | 169 | 0 |
| K030860 | ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 | Monobind | 2003-08-22 | 157 | 0 |
| K023369 | ACCESS TOTAL T4 ASSAY | Beckman Coulter, Inc. | 2002-12-09 | 62 | 5 |
| K001603 | REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) | Repromedix Corp. | 2000-10-05 | 134 | 0 |
| K000600 | SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS | Syva Co., Dade Behring, Inc. | 2000-03-27 | 33 | 0 |
| K991432 | BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 | Biocheck, Inc. | 1999-06-02 | 37 | 1 |
| K982298 | OPTICOAT T4 EIA KIT | Biotecx Laboratories, Inc. | 1999-02-03 | 217 | 0 |
| K983440 | ABBOTT ARCHITECT TOTAL T4 | Abbott Laboratories | 1998-11-25 | 57 | 0 |
| K981377 | ACE T4 REAGENT T4 CALIBRATORS | Schiapparelli Biosystems, Inc. | 1998-06-10 | 55 | 0 |
| K972974 | ACCUWELL T4-EIA | Neometrics, Inc. | 1997-10-06 | 56 | 0 |
| K971709 | TOTAL THROXINE MICROPLATE EIA(225-300) | Monobind | 1997-06-16 | 39 | 0 |
| K971269 | DSL ACTIVE T4 EIA | Diagnostic Systems Laboratories, Inc. | 1997-05-22 | 48 | 0 |
| K971203 | SYNCHRON SYSTEMS THYROXINE REAGENT | Beckman Instruments, Inc. | 1997-05-16 | 45 | 0 |
| K964721 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-12-18 | 23 | 1 |
| K951014 | ISOLAB'S T4 TEST KIT | Isolab, Inc. | 1996-10-18 | 592 | 0 |
| K962211 | UBI MAGIWEL THYROXINE (T4) QUANTITATIVE | United Biotech, Inc. | 1996-07-08 | 28 | 0 |
| K952751 | BIOCIRCUITS IOS T4/TU TEST CARTRIDGES | Biocircuits Corp. | 1995-11-20 | 158 | 0 |
| K953837 | BIOCIRCUITS IOS T4 TEST CARTRIDGE | Biocircuits Corp. | 1995-11-20 | 97 | 0 |
| K951321 | RADIAS NEONATAL T4 ENZYME IMMUNOASSAY | Bio-Rad | 1995-08-24 | 154 | 0 |
| K950588 | T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 | Biomerica, Inc. | 1995-06-29 | 140 | 0 |
| K946163 | RADIAS TOTAL T4 ENZYME IMMUNOASSAY | Bio-Rad | 1995-02-22 | 65 | 0 |
| K944703 | THYROXINE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1994-12-09 | 77 | 0 |
| K943019 | CEDIA T4 MAB ASSAY | Microgenics Corp. | 1994-10-20 | 118 | 0 |
| K942575 | CEDIA T4 MAB ASSAY | Microgenics Corp. | 1994-07-28 | 58 | 0 |
| K941042 | CEDIA T4 MAB ASSAY | Microgenics Corp. | 1994-04-26 | 50 | 0 |
| K935880 | CEDIA T4 MAB ASSAY MODIFICATION | Microgenics Corp. | 1994-03-03 | 87 | 0 |
| K932605 | COBAS (R) CORE T4 EIA | Roche Diagnostic Systems, Inc. | 1994-01-24 | 241 | 0 |
| K926475 | ACCESS(R) THYROXINE ASSAY | Bio-Rad Laboratories, Inc. | 1993-06-15 | 168 | 1 |
| K926393 | VIDAS THYROXINE (T4) ASSAY (T4) | Biomerieux Vitek, Inc. | 1993-05-13 | 143 | 0 |
| K922433 | VISTA THYROXINE (T-4) ASSAY -- MODIFICATION | Syva Co. | 1992-09-18 | 155 | 0 |
| K921904 | THYROXINE (FPIA) KIT | Tudor Laboratories, Inc. | 1992-06-24 | 64 | 0 |
| K920712 | MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1992-03-27 | 38 | 0 |
| K915194 | CEDIA T4 | Boehringer Mannheim Corp. | 1991-12-09 | 20 | 0 |
| K912616 | TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES | Technicon Instruments Corp. | 1991-09-25 | 104 | 0 |
| K911217 | SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) | Serono-Baker Diagnostics, Inc. | 1991-08-16 | 150 | 0 |
| K910261 | IMMULITE(TM) TOTAL T4 | Cirrus Diagnostics, Inc. | 1991-04-16 | 84 | 0 |
| K903095 | IL THYROXINE (T4) ASSAY SYSTEM | Instrumentation Laboratory CO | 1990-08-23 | 41 | 0 |
| K897072 | NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR | Kallestad Diag, A Div. of Erbamont, Inc. | 1990-03-29 | 97 | 0 |
| K897193 | OPUS T4 TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1990-03-19 | 80 | 0 |
| K897144 | THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1990-03-15 | 78 | 0 |
| K896982 | AIA-PACK T4 | Tosoh Corp. | 1990-03-09 | 80 | 0 |
| K896865 | VITRO T4-EIA-XT | In Vitro Diagnostics, Inc. | 1990-01-30 | 55 | 0 |
| K896329 | D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. | Photec Diagnostics, Inc. | 1989-12-12 | 40 | 0 |
| K892853 | T4 CLASP-BEAD EIA KIT | Biotecx Laboratories, Inc. | 1989-05-22 | 34 | 0 |
| K890831 | EMIT CONVENIENCE PACK: THYROXINE ASSAY | Syva Co. | 1989-04-14 | 52 | 0 |
| K884260 | THYROXINE MICROASSAY | Diamedix Corp. | 1989-02-23 | 135 | 0 |
| K885258 | ACA THYROXINE (T4 E) METHOD | The DU Pont Co. | 1989-02-17 | 56 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda