Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
CGC — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
57 daysmedian FDA review time
115 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961276 | GASTRIN EIA MODEL 06B-555017 | Biosyn , Ltd. | 1996-05-30 | 57 | 0 |
| K842079 | GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY | Immuno Nuclear Corp. | 1984-06-26 | 34 | 0 |
| K841963 | GASTRIN RIA | Syncor Intl. Corp. | 1984-06-25 | 42 | 0 |
| K833489 | DPC GASTRIN KIT | Diagnostic Products Corp. | 1984-01-30 | 115 | 0 |
| K831075 | BLOOD GAS & FLAME PHOTOMETER INSTRU- | United Diagnostics, Inc. | 1983-06-22 | 79 | 0 |
| K821175 | GASTRIN RADIOIMMUNOASSAY KIT (125-I) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-05-14 | 18 | 0 |
| K812727 | GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT | Immuno Nuclear Corp. | 1981-11-05 | 38 | 0 |
| K812004 | GASTRIN RIA DIAGNOSTIC KIT | Abbott Laboratories | 1981-07-28 | 14 | 0 |
| K810722 | GASTRIN RADIOIMMUNOASSAY TEST | Clinical Assays, Inc. | 1981-05-27 | 71 | 0 |
| K771953 | GASTRIN RIA MODULE | Inter Science Institute | 1978-01-20 | 95 | 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