FDA applicant
Wallac Oy, Subsidiary of Perkinelmer
FDA records 2 decisions for Wallac Oy, Subsidiary of Perkinelmer (Waltham, MA) from 2010 to 2018: 2 510(k) clearances. Most are in product codes JNO (N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin) and NQL (System, Test, Amino Acids, Free Carnitines And…). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Wallac Oy, Subsidiary of Perkinelmer, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Wallac Oy, Subsidiary of Perkinelmer’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Wallac Oy, Subsidiary of Perkinelmer’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Wallac”
FDA records each applicant name separately; these may or may not be the same firm.