FDA applicant

Mitsubishi Kagaku Iatron

Seattle, WA4 decisions2008–20093 recalls

FDA records 4 decisions for Mitsubishi Kagaku Iatron (Seattle, WA) from 2008 to 2009: 4 510(k) clearances. Most are in product codes NBC (Test, Natriuretic Peptide) and GHH (Fibrin Split Products). 3 recalls are 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 Mitsubishi Kagaku Iatron’s devices, and how often a recall has named them.

FDA decisions per year

3in 2009

2008high 3 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2018

2008high 2 (2018) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Mitsubishi Kagaku Iatron by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mitsubishi Kagaku Iatron’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Mitsubishi”

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

Mitsubishi Intl. Corp. 5 Mitsubishi Heavy Industries, Ltd. 3 Mitsubishi Electronics America, Inc. 3 Mitsubishi Chemical Medience Corporation 3 Mitsubishi Cable America, Inc. 3 Mitsubishi Yuka America, Inc. 2 Mitsubishi Electric Corporation Kyoto Works 1

Mitsubishi Kagaku Iatron

Which product codes does it file in?

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 “Mitsubishi”