510(k) Report

FDA applicant

Mitsubishi Yuka America, Inc.

Washington, DC2 decisions1991–19920 recalls

FDA records 2 decisions for Mitsubishi Yuka America, Inc. (Washington, DC) from 1991 to 1992: 2 510(k) clearances. Most are in product codes CKG (Radioimmunoassay, Acth) and JKR (Radioimmunoassay, Calcitonin). 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 Mitsubishi Yuka America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mitsubishi Yuka America, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mitsubishi Yuka America, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CKGRadioimmunoassay, Acth1decision
  • JKRRadioimmunoassay, Calcitonin1decision

What has FDA decided for it lately?

  • K915727Acth Irma Kit II Mitsubishi YukaMitsubishi Yuka America, Inc. · 1992
  • K912536Calcitonin Kit Mitsubishi YukaMitsubishi Yuka America, Inc. · 1991

All 2 as Mitsubishi Yuka America, Inc. →

Other applicant names beginning “Mitsubishi”

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

Mitsubishi Intl. Corp. 5Mitsubishi Kagaku Iatron 4Mitsubishi Heavy Industries, Ltd. 3Mitsubishi Electronics America, Inc. 3Mitsubishi Chemical Medience Corporation 3Mitsubishi Cable America, Inc. 3Mitsubishi Electric Corporation Kyoto Works 1