Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LFQ · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
28 daysmedian FDA review time
59 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K860111 | URIC ACID REAGENT SET | Technostics Intl. | 1986-02-19 | 37 | 0 |
| K860142 | URIC ACID REAGENT SET (COLORIMETRIC) | Sterling Diagnostics, Inc. | 1986-02-11 | 28 | 1 |
| K844075 | URIC ACID REAGENT SET | Livonia Diagnostics, Inc. | 1984-10-30 | 11 | 0 |
| K812313 | SANDARE URIC ACID PROCEDURE | Sandare Chemical Co., Inc. | 1981-09-01 | 15 | 0 |
| K811764 | URIC ACID REAGENT SET | Anco Medical Reagents & Assoc. | 1981-08-20 | 59 | 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