Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Immuno Assay Corp. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
19 daysmedian FDA review time
75 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K833842 | RIA COAT DIGOXIN | Immuno Assay Corp. | 1984-01-17 | 75 | 0 |
| K833745 | RIACOAT T-4 | Immuno Assay Corp. | 1984-01-04 | 70 | 0 |
| K820089 | TSH (RIA) KIT | Immuno Assay Corp. | 1982-01-28 | 15 | 0 |
| K820074 | CORTISOL (RIA) KIT | Immuno Assay Corp. | 1982-01-28 | 16 | 0 |
| K811954 | COMBO-FER IRON DIAGNOSTIC | Immuno Assay Corp. | 1981-07-27 | 19 | 0 |
| K811725 | TBG DIAGNOSTIC KIT | Immuno Assay Corp. | 1981-07-10 | 22 | 0 |
| K811213 | T3 (RIA) KIT | Immuno Assay Corp. | 1981-05-29 | 25 | 0 |
| K811212 | DIGOXIN (RIA) KIT | Immuno Assay Corp. | 1981-05-21 | 17 | 0 |
| K810857 | T3 UPTAKE KIT | Immuno Assay Corp. | 1981-04-08 | 9 | 0 |
| K810811 | T4 RIA KIT | Immuno Assay Corp. | 1981-04-07 | 14 | 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