510(k) Report

FDA applicant

Mitsubishi Chemical Medience Corporation

Bethesda, MD3 decisions2011–20140 recalls

FDA records 3 decisions for Mitsubishi Chemical Medience Corporation (Bethesda, MD) from 2011 to 2014: 3 510(k) clearances. Most are in product codes JIT (Calibrator, Secondary) and MMI (Immunoassay Method, Troponin Subunit). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Mitsubishi Chemical Medience CO”.

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 Chemical Medience Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011: 12013: 12014: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Mitsubishi Chemical Medience Corporation by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mitsubishi Chemical Medience Corporation’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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Which product codes does it file in?

  • JITCalibrator, Secondary2decisions
  • MMIImmunoassay Method, Troponin Subunit1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K100130Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2Mitsubishi Chemical Medience CO · 20112cite it

What has FDA decided for it lately?

  • K130603Pathfast CTNL CalibratorsMitsubishi Chemical Medience Corporation · 2014
  • K130628Pathfast CK-MB-II CalibratorsMitsubishi Chemical Medience Corporation · 2013
  • K100130Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2Mitsubishi Chemical Medience CO · 2011

All 2 as Mitsubishi Chemical Medience Corporation →The one decision as Mitsubishi Chemical Medience CO →

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 Cable America, Inc. 3Mitsubishi Yuka America, Inc. 2Mitsubishi Electric Corporation Kyoto Works 1