Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CDP — Predicate Candidate Screening
144 FDA 510(k) clearances under this product code; the 50 most recent screened below.
50 daysmedian FDA review time
122 days90th percentile
144clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001607 | REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) | Repromedix Corp. | 2000-10-05 | 134 | 0 |
| K991692 | CHIRON DIAGNOSTICS ACS: 180 FT3 | Chiron Diagnostics Corp. | 1999-06-18 | 31 | 0 |
| K991311 | TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 | Biocheck, Inc. | 1999-06-02 | 47 | 0 |
| K991252 | AIA-PACK FT3 ASSAY | Tosoh Medics, Inc. | 1999-05-11 | 28 | 0 |
| K981824 | OPTICOAT T3 EIA KIT | Biotecx Laboratories, Inc. | 1998-12-22 | 214 | 0 |
| K983439 | ABBOTT ARCHITECT FREE T3 | Abbott Laboratories | 1998-11-20 | 52 | 1 |
| K983434 | ABBOTT ARCHITECT TOTAL T3 | Abbott Laboratories | 1998-11-20 | 52 | 0 |
| K974027 | AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK | Alfa Biotech (Uk) , Ltd. | 1998-02-02 | 102 | 0 |
| K974634 | IMMULITE FREE T3 | Diagnostic Products Corp. | 1998-01-02 | 21 | 2 |
| K973966 | ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | Beckman Instruments, Inc. | 1997-10-31 | 14 | 2 |
| K971779 | TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA | Monobind | 1997-06-16 | 33 | 0 |
| K971270 | DSL ACTIVE T3 EIA | Diagnostic Systems Laboratories, Inc. | 1997-05-22 | 48 | 0 |
| K965058 | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT | Nichols Institute Diagnostics | 1997-03-11 | 83 | 0 |
| K970016 | VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM. | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-01-30 | 28 | 1 |
| K963127 | ELECSYS FT3 | Boehringer Mannheim Corp. | 1996-12-16 | 126 | 0 |
| K962760 | ENZYMUN-TEST FT3 | Boehringer Mannheim Corp. | 1996-11-29 | 136 | 0 |
| K964310 | VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GE | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-11-27 | 29 | 3 |
| K963687 | AIA-PACK FT3 ASSAY | Tosoh Medics, Inc. | 1996-11-08 | 53 | 0 |
| K963833 | IMX FREE TRIIODOTHYRONINE (FREE T3) | Abbott Laboratories | 1996-10-30 | 36 | 0 |
| K963827 | AXSYM FREE TRIIODOTHYRONINE (FREE T3) | Abbott Laboratories | 1996-10-30 | 36 | 0 |
| K962508 | ELECSYS T3 | Boehringer Mannheim Corp. | 1996-08-15 | 49 | 0 |
| K962355 | FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 | Bayer Corp. | 1996-07-12 | 24 | 0 |
| K961236 | UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE | United Biotech, Inc. | 1996-05-30 | 62 | 0 |
| K960913 | ACCESS FREE T3 ASSAY | Bio-Rad Laboratories, Inc. | 1996-03-29 | 23 | 1 |
| K960412 | T-3 MICROWELL EIA MODEL 7013 | Biomerica, Inc. | 1996-03-19 | 50 | 0 |
| K960550 | ACTIVE T3 RIA | Diagnostic Systems Laboratories, Inc. | 1996-03-06 | 27 | 0 |
| K952557 | TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS | Sigma Diagnostics, Inc. | 1996-01-24 | 236 | 0 |
| K955435 | ACCESS TOTAL T3 ASSAY (MODIFICATION) | Bio-Rad Laboratories, Inc. | 1996-01-24 | 114 | 1 |
| K953160 | OPUS T3 | Behring Diagnostics, Inc. | 1995-08-24 | 48 | 0 |
| K944808 | IMX T3 ASSAY | Organon Teknika Corp. | 1994-12-09 | 71 | 0 |
| K940833 | ACCESS(R) TOTAL T3 | Bio-Rad Laboratories, Inc. | 1994-09-07 | 196 | 1 |
| K936229 | AIA-PACK TT3 ASSAY | Tosoh Medics, Inc. | 1994-07-14 | 197 | 1 |
| K934517 | AXSYM TOTAL T3 | Abbott Laboratories | 1994-06-21 | 274 | 0 |
| K934764 | VIDAS T3 ASSAY | Biomerieux Vitek, Inc. | 1994-03-22 | 169 | 0 |
| K932747 | CIBA CORNING ACS FREE T3 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1993-12-03 | 178 | 0 |
| K932608 | COBAS(R) CORE T3 EIA | Roche Diagnostic Systems, Inc. | 1993-12-03 | 189 | 0 |
| K931600 | CHEMILUMINESCENCE FREE T3 IMMUNOASSAY | Nichols Institute | 1993-09-08 | 160 | 0 |
| K926345 | TRIODOTHYRONINE (TC) COATED TUBE RIA | Monobind | 1993-02-25 | 70 | 0 |
| K925436 | MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1992-12-28 | 61 | 0 |
| K923571 | VISTA TRIIODOTHYRONINE ASSAY | Syva Co. | 1992-10-15 | 90 | 0 |
| K922771 | KODAK AMERLEX MAB FT3 ASSAY | Eastman Kodak Company | 1992-10-14 | 127 | 0 |
| K923258 | TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE | Heraeus Kulzer, Inc. | 1992-09-23 | 83 | 0 |
| K923015 | TOTAL T3 CHEMILUMINESCENCE ASSAY | Nichols Institute Diagnostics | 1992-09-02 | 72 | 0 |
| K914467 | MILENIA TOTAL T3 | Diagnostic Products Corp. | 1992-02-06 | 122 | 0 |
| K915792 | DOCUMENT CK ISOENZYMES CONTROL | Casco Standards | 1992-02-06 | 44 | 0 |
| K910737 | SRI T3 IMMOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1991-05-01 | 69 | 0 |
| K905410 | OPUS T3 TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1991-02-04 | 63 | 0 |
| K905214 | IMMULITE (TM) TOTAL T3 | Cirrus Diagnostics, Inc. | 1991-02-01 | 73 | 0 |
| K905656 | FLAGEN TRIIODOTHYRONINE (T3) ASSAY | Cyberfluor, Inc. | 1991-01-23 | 37 | 0 |
| K905261 | IMX FREE TRIIODOTHYRONINE | Abbott Laboratories | 1991-01-23 | 63 | 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