Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CGF — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970915 | DSL ESTRONE-SULFATE RIA | Diagnostic Systems Laboratories, Inc. | 1997-05-16 | 65 | 0 |
| K935013 | DSL ESTRONE (DSL 8700) | Diagnostic Systems Laboratories, Inc. | 1994-06-16 | 239 | 4 |
| K864966 | ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE | Diagnostics Biochem Canada, Inc. | 1987-01-09 | 18 | 0 |
| K833406 | IMMOPHASE D-TE 3 RADIOIMMUNOASSAY | Corning Medical & Scientific | 1984-01-24 | 116 | 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