510(k) Report

FDA applicant

Wallac Oy, Subsidiary of Perkinelmer

Waltham, MA2 decisions2010–20180 recalls

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, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

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

2010: 12018: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Wallac Oy, Subsidiary of Perkinelmer by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Wallac”

FDA records each applicant name separately; these may or may not be the same firm.