510(k) Report

FDA applicant

Hitachi Chemical Diagnostics, Inc.

Mountain View, CA16 decisions2003–20211 recall

FDA records 16 decisions for Hitachi Chemical Diagnostics, Inc. (Mountain View, CA) from 2003 to 2021: 16 510(k) clearances. Most are in product codes DHB (System, Test, Radioallergosorbent (Rast)…) and JFJ (Catalytic Methods, Amylase). Its devices cite 24 predicates, 1 of them its own earlier devices. 1 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 Hitachi Chemical Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2011: 12012: 32013: 72014: 12019: 12021: 1
2007high 7 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Hitachi Chemical Diagnostics, 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

Which product codes does it file in?

  • DHBSystem, Test, Radioallergosorbent (Rast) Immunological5decisions
  • JFJCatalytic Methods, Amylase1decision
  • DCNSystem, Test, C-Reactive Protein1decision
  • CICCresolphthalein Complexone, Calcium1decision
  • CKANadh Oxidation/Nad Reduction, Alt/Sgpt1decision
  • JGQTurbidimetric, Total Protein1decision

Also: CDN (1), KHS (1), CFR (1), CHH (1), CJE (1), CIG (1).

Whose devices does it build on?

Its devices cite 24 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K030590Cla Allergen-Specific Ige Assay-Latex Allergen (K82)Hitachi Chemical Diagnostics, Inc. · 20031cites it

What has FDA decided for it lately?

  • K193613Allergen-Specific IgE Assay 12 Allergen BundleHitachi Chemical Diagnostics, Inc. · 2021
  • K182793AP3600 Automated InstrumentHitachi Chemical Diagnostics, Inc. · 2019
  • K140248S Test Reagent Cartridge Carbon Dioxide (CO2)Hitachi Chemical Diagnostics, Inc. · 2014
  • K132462S Test Reagent Cartridge Bun and S Test Reagent Cartridge CreHitachi Chemical Diagnostics, Inc. · 2013
  • K130685Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and AmyHitachi Chemical Diagnostics, Inc. · 2013
  • K120945Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test Reagent Cartridge AstHitachi Chemical Diagnostics, Inc. · 2013
  • K131051Hitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (Alb)Hitachi Chemical Diagnostics, Inc. · 2013
  • K131217S Test Reagent Cartridge Total BilirubinHitachi Chemical Diagnostics, Inc. · 2013

All 16 as Hitachi Chemical Diagnostics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K051677OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi…Dec 21, 2012Class III

Other applicant names beginning “Hitachi”

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

Hitachi Medical Systems America, Inc. 100Hitachi Medical Corp. of America 32Hitachi Healthcare Americas 17Hitachi Medical Corp. 12Hitachi, Ltd. 8Hitachi Aloka Medical, Ltd. 6Hitachi, Ltd., Health Care Company 4Hitachi Aloka Medical America, Inc. 3Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical 3Hitachi Sales Corporation of America 2Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha 2Hitachi, Ltd., Power Systems Group 2