Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
CIQ · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
50 daysmedian FDA review time
81 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K881173 | ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) | Tech-Co, Inc. | 1988-06-07 | 81 | 0 |
| K860216 | SGOT (AST) REAGENT SET | Sterling Diagnostics, Inc. | 1986-04-03 | 71 | 1 |
| K855189 | GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET | Technostics Intl. | 1986-01-14 | 19 | 0 |
| K844322 | SGOT REAGENT SET | Livonia Diagnostics, Inc. | 1984-11-27 | 20 | 0 |
| K841065 | SGOT REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K821209 | SGOT REAGENT SET | Omega Medical Electronics | 1982-07-14 | 78 | 0 |
| K820466 | SGOT REAGENT SET | Anco Medical Reagents & Assoc. | 1982-03-11 | 17 | 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