FDA applicant

Sekisui Diagnostics P.E.I., Inc.

Charlottetown,, CA6 decisions2011–20220 recalls

FDA records 6 decisions for Sekisui Diagnostics P.E.I., Inc. (Charlottetown,, CA) from 2011 to 2022: 6 510(k) clearances. Most are in product codes LDP (Colorimetry, Acetaminophen) and JGJ (Photometric Method, Magnesium). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 Sekisui Diagnostics P.E.I., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2011high 2 (2019) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Sekisui Diagnostics P.E.I., Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sekisui Diagnostics P.E.I., Inc.’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) Report

Other applicant names beginning “Sekisui”

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

SEKISUI Diagnostics, LLC 6 Sekisui Medical Co., Ltd. 1

Sekisui Diagnostics P.E.I., Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Sekisui”