Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NYO · 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) |
|---|---|---|---|---|---|
| K202541 | EliA RNA Pol III | Phadia AB | 2021-09-13 | 376 | 0 |
| K172078 | ImmuLisa Enhanced RNA POL III Antibody ELISA | Immco Diagnostics, Inc. | 2018-03-30 | 263 | 0 |
| K070066 | QUANTA LITE RNA POL III ELISA | Inova Diagnostics, Inc. | 2007-04-11 | 93 | 0 |
| K060431 | ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 | Mbl International Corporation | 2006-06-19 | 118 | 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