Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CDN · Predicate Candidate Screening
16 FDA 510(k) clearances under this product code; the 50 most recent screened below.
55 daysmedian FDA review time
268 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Ortho-Clinical Diagnostics, Inc. | 2019-03-14 | 29 | 0 |
| K132462 | S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CR | Hitachi Chemical Diagnostics, Inc. | 2013-10-28 | 82 | 0 |
| K123322 | ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID | Alfa Wassermann Diagnostics Technologies, LLC | 2013-05-21 | 207 | 0 |
| K113389 | ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,AC | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-08-10 | 268 | 0 |
| K103615 | ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATINI | Alfa Wassermann Diagnostic Technologies, Inc. | 2011-09-08 | 273 | 1 |
| K001885 | VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMIST | Ortho-Clinical Diagnostics, Inc. | 2000-07-20 | 29 | 2 |
| K972012 | CHOLESTECH BUN/CREATININE TEST SYSTEM | Cholestech Corp. | 1997-07-24 | 55 | 0 |
| K961196 | EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-15 | 49 | 1 |
| K943042 | BUN QVET | Prisma Systems | 1994-12-29 | 185 | 0 |
| K922969 | KING DIAGNOSTICS UREA NITROGEN REAGENT | King Diagnostics, Inc. | 1992-10-13 | 116 | 0 |
| K914903 | QUICKSTART UREA NITROGEN | Em Diagnostic Systems, Inc. | 1991-12-31 | 60 | 0 |
| K822154 | UREA NITROGEN (ENZYMATIC) DETERMINATION | The Dow Chemical Co. | 1982-08-05 | 13 | 0 |
| K802518 | BUN REAGENT ASTRA 4 & 8 ANALYZERS | Nobel Scientific Industries, Inc. | 1980-11-12 | 28 | 0 |
| K792328 | STATTEK BUN | Boehringer Mannheim Corp. | 1979-12-18 | 29 | 0 |
| K781253 | BUN (UREASE) REAGENT | Coulter Electronics, Inc. | 1978-08-21 | 31 | 0 |
| K771442 | MULTISTAT III UREA NITROGEN TEST | Instrumentation Laboratory CO | 1977-08-22 | 21 | 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