Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Wallac Oy, A Subsidiary of Perkinelmer, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133652 | GSP NEONATAL TOTAL GALACTOSE KIT | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2014-04-28 | 152 | 0 |
| K110274 | AUTODELFIA NEONATAL IRT KIT | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2011-06-10 | 130 | 0 |
| K103484 | GSP NEONATAL THYROXINE (T4) | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2011-04-22 | 147 | 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