Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CHO · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
65 daysmedian FDA review time
133 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K860253 | AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT) | Amersham Corp. | 1986-03-14 | 49 | 0 |
| K844135 | PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU | Immuno Nuclear Corp. | 1985-03-05 | 133 | 0 |
| K841478 | RIANEN CYCLIC-AMP RADIOIMMUNOASSAY | New England Nuclear | 1984-06-14 | 66 | 0 |
| K823504 | CYCLIC ADENOSINE MONOPHOSHATE BY RADIO | Immuno Nuclear Corp. | 1983-01-28 | 65 | 0 |
| K811746 | KING DIAGNOSTICS CHOLESTEROL-FE TEST | King Diagnostics, Inc. | 1981-07-10 | 18 | 0 |
| K811273 | CYCLIC AMP RADIOIMMUNOASSAY KIT [125I] | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-05-27 | 20 | 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