Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JGZ — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
48 daysmedian FDA review time
120 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K904049 | ROCHE COBAS READY RENAL PROFILE REAGENT STRIP | Roche Diagnostic Systems, Inc. | 1990-10-12 | 38 | 0 |
| K896236 | COBAS READY BUN REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-27 | 120 | 0 |
| K883327 | CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST | Heraeus Kulzer, Inc. | 1989-01-23 | 168 | 0 |
| K863901 | IQ UREA NITROGEN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-11-24 | 48 | 0 |
| K842772 | PHARMACIA B2-MICRO RIA | Pharmacia, Inc. | 1984-11-01 | 108 | 0 |
| K840213 | BLOOD UREA NITROGEN REAGENT SYS | Sclavo, Inc. | 1984-03-19 | 60 | 0 |
| K820418 | K.D. COLORIMETRIC BLOOD UREA N2 TEST | King Diagnostics, Inc. | 1982-03-11 | 23 | 0 |
| K810087 | UREA NITROGEN, KINETIC | Bio-Analytics Laboratories, Inc. | 1981-02-26 | 44 | 0 |
| K801269 | SERALYZER BLOOD UREA NITROGEN(BUN) | Miles Laboratories, Inc. | 1980-07-08 | 41 | 0 |
| K792362 | BLOOD UREA NITROGEN REAGENT | Connecticut Diagnostics, Ltd. | 1979-12-06 | 15 | 0 |
| K770504 | REAGENT SYSTEM | American Monitor Corp. | 1977-06-27 | 103 | 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