Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CDL — Predicate Candidate Screening
16 FDA 510(k) clearances under this product code; the 50 most recent screened below.
37 daysmedian FDA review time
72 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K896845 | RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT | Reagents Applications, Inc. | 1990-02-16 | 72 | 0 |
| K893128 | STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 | Stanbio Laboratory | 1989-07-25 | 91 | 0 |
| K871651 | COLORIMETRIC BUN REAGENT KIT | Biochemical Trade, Inc. | 1987-05-12 | 14 | 0 |
| K864742 | UREA NITROGEN(BUN), COLORIMETRIC METHOD | Tech-Co, Inc. | 1987-01-13 | 40 | 0 |
| K863889 | UREA NITROGEN TEST | U. S. Diagnostics, Inc. | 1986-11-24 | 49 | 0 |
| K863076 | UREAFAST | J. D. Assoc. | 1986-09-09 | 28 | 0 |
| K860154 | BUN (ENZYMATIC BERTHELOT) REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-06 | 21 | 1 |
| K831414 | COLORIMETRIC BUN | Bio-Analytics Laboratories, Inc. | 1983-06-16 | 45 | 0 |
| K822237 | UREA NITROGEN REAGENT SET (MOD. BERTHEL | Sterling Biochemical, Inc. | 1982-08-16 | 19 | 0 |
| K810261 | EUROCHIMA UREA NITROGEN | Volu Sol Medical Industries | 1981-02-10 | 11 | 0 |
| K801727 | DATA-ZYME UREA NITROGEN, COLORIMETRIC | Data Medical Associates, Inc. | 1980-09-09 | 47 | 0 |
| K800902 | BUN-COLOR 2, BLOOD UREA NITROGEN TEST | Sclavo, Inc. | 1980-06-09 | 52 | 0 |
| K792417 | ELVI BLOOD UREA NITROGEN | Volu Sol Medical Industries | 1979-12-07 | 11 | 0 |
| K781899 | UREA NITROGEN TEST | Wako Intl., Inc. | 1978-12-20 | 37 | 0 |
| K781306 | UREA NITROGEN TEST KIT | Analytical & Research Chemicals, Inc. | 1978-08-31 | 34 | 0 |
| K761152 | S-UREA-N, IN VITRO DIAG FOR BUN | Advanced Biomedical Methods, Inc. | 1976-12-09 | 10 | 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