Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CDQ — Predicate Candidate Screening
117 FDA 510(k) clearances under this product code; the 50 most recent screened below.
46 daysmedian FDA review time
134 days90th percentile
117clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203771 | Urea Nitrogen2 | Abbott Ireland Diagnostics Division | 2022-05-31 | 524 | 0 |
| K140690 | BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2014-09-02 | 167 | 0 |
| K110675 | EASYRA UREA NITROGEN AND CREATININE REAGENTS | Medica Corp. | 2011-04-21 | 42 | 0 |
| K073295 | UREA/BUN, SCAL, NORTROL, ABTROL | Thermofisher Scientific OY | 2008-05-29 | 188 | 0 |
| K070146 | ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP | Horiba Abx | 2007-10-12 | 269 | 0 |
| K060120 | TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM | Teco Diagnostics | 2006-03-27 | 69 | 0 |
| K041051 | RAICHEM BUN RATE REAGENT (LIQUID) | Hemagen Diagnostics, Inc. | 2004-06-30 | 72 | 0 |
| K024182 | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORA | Precision Systems, Inc. | 2003-03-03 | 74 | 0 |
| K021385 | ATAC PAK BUN REAGENT | Elan Diagnostics | 2002-07-12 | 71 | 0 |
| K012649 | RAICHEM BUN RATE REAGENT | Hemagen Diagnostics, Inc. | 2001-10-15 | 63 | 0 |
| K012260 | WIENER LAB. UREA UV CINETICA AA | Wiener Laboratories Saic | 2001-09-19 | 63 | 0 |
| K011596 | UREA NITROGEN (BUN) LIQUID REAGENT | Jas Diagnostic, Inc. | 2001-07-17 | 54 | 0 |
| K002694 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 | Diagnostic Chemicals , Ltd. | 2000-09-15 | 17 | 0 |
| K000958 | ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS | Elan Holdings, Inc. | 2000-05-24 | 61 | 0 |
| K993925 | WAKO L-TYPE UN TEST | Wako Chemicals USA, Inc. | 2000-04-03 | 137 | 0 |
| K993178 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 | Diagnostic Chemicals , Ltd. | 1999-10-18 | 25 | 0 |
| K992800 | SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100 | Sigma Diagnostics, Inc. | 1999-09-28 | 40 | 0 |
| K990980 | BUN, MODEL BU 104-01 | A.P. Total Care, Inc. | 1999-05-25 | 63 | 0 |
| K982236 | SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT | Sigma Diagnostics, Inc. | 1998-08-05 | 41 | 0 |
| K981918 | UREA | Abbott Laboratories | 1998-07-28 | 57 | 1 |
| K981123 | UREA | Trace Scientific , Ltd. | 1998-04-24 | 28 | 0 |
| K981106 | UREA NITROGEN (BUN) LIQUID REAGENT | Teco Diagnostics | 1998-04-16 | 21 | 0 |
| K980057 | CARESIDE BUN | Exigent Diagnostics, Inc. | 1998-02-05 | 30 | 0 |
| K974337 | IL TEST UREA NITROGEN | Instrumentation Laboratory CO | 1997-12-17 | 29 | 0 |
| K973931 | UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30 | Diagnostic Chemicals , Ltd. | 1997-11-24 | 40 | 0 |
| K971309 | UREA | Derma Media Lab., Inc. | 1997-08-01 | 115 | 0 |
| K972671 | BUN (LIQUID) REAGENT SET | Pointe Scientific, Inc., | 1997-07-20 | 4 | 0 |
| K971967 | BUN | Carolina Liquid Chemistries Corp. | 1997-06-17 | 20 | 0 |
| K971477 | UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION T | Trace America, Inc. | 1997-05-27 | 34 | 0 |
| K962418 | UREA NITROGEN (BUN) LIQUI-UV | Stanbio Laboratory | 1996-12-26 | 185 | 0 |
| K960115 | HICHEM BUN/UREA REAGENT KIT | Elan Pharma, Inc. | 1996-03-29 | 78 | 0 |
| K954000 | ROCHE REAGENT FOR BUN | Roche Diagnostic Systems, Inc. | 1995-10-25 | 61 | 0 |
| K952742 | BLOOD UREA NITROGEN REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-11 | 56 | 0 |
| K942984 | BUN REAGENT | American Research Products Co. | 1995-03-01 | 254 | 0 |
| K944250 | UREA NITROGEN REAGENT | Olympus Corp of America | 1995-02-08 | 160 | 0 |
| K934533 | BUN-300/BUN-500 UREA NITROGEN REAGENT | Horizon Diagnostics, Inc. | 1993-11-26 | 70 | 0 |
| K923506 | UREA KIT | Randox Laboratories, Ltd. | 1993-09-27 | 439 | 1 |
| K932161 | UREA NITROGEN TEST ITEM NUMBER 65408 | Em Diagnostic Systems, Inc. | 1993-09-08 | 127 | 0 |
| K931745 | OLYMPUS REPLY UREA NITROGEN REAGENT | Olympus Corp. | 1993-08-19 | 136 | 0 |
| K925002 | UREA NITROGEN TEST | Em Diagnostic Systems, Inc. | 1993-01-04 | 94 | 0 |
| K924693 | OLYMPUS BUN REAGENT | Olympus Corp. | 1992-11-25 | 70 | 0 |
| K923035 | MILES URINE UREA NITROGEN METHOD | Heraeus Kulzer, Inc. | 1992-09-09 | 82 | 0 |
| K922597 | OLYMPUS UREA NITROGEN (BUN) REAGENT | Olympus Corp. | 1992-07-10 | 38 | 0 |
| K914877 | IL TEST(TM) UREA NITROGEN | Instrumentation Laboratory CO | 1992-03-11 | 134 | 0 |
| K911248 | SYNERMED UREA NITROGEN REAGENT KIT | Synermed, Inc. | 1991-06-03 | 74 | 0 |
| K905602 | ECLIPSE ICA BUN | Biotope, Inc. | 1991-01-16 | 34 | 0 |
| K903334 | UREA NITROGEN TEST | Em Diagnostic Systems, Inc. | 1990-09-07 | 44 | 0 |
| K902175 | COULTER UREA NITROGEN REAGENT | Coulter Corp. | 1990-06-12 | 29 | 0 |
| K901123 | CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN | Technicon Instruments Corp. | 1990-05-10 | 59 | 0 |
| K900394 | AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583 | American Research Products Co. | 1990-04-11 | 72 | 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