FDA applicant

Wallac Oy, A Subsidiary of Perkinelmer, Inc.

Waltham, MA4 decisions2011–20181 recall

FDA records 4 decisions for Wallac Oy, A Subsidiary of Perkinelmer, Inc. (Waltham, MA) from 2011 to 2018: 4 510(k) clearances. Most are in product codes JNO (N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin) and KLI (Enzyme Immunoassay, Non-Radiolabeled, Total…). Its devices cite 4 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Wallac Oy, A Subsidiary of Perkinelmer”.

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, A Subsidiary of Perkinelmer, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2017

2011high 1 (2017) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Wallac Oy, A Subsidiary of Perkinelmer, Inc. by year, 2011–2026Sources: 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.

Wallac OY 24 Wallac Oy, Subsidiary of Perkinelmer 2

Wallac Oy, A Subsidiary of Perkinelmer, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Wallac”