510(k) Report

FDA applicant

Tyson Bioresearch, Inc.

Chu-Nan, Miao-Li County, TW13 decisions2006–20180 recalls

FDA records 13 decisions for Tyson Bioresearch, Inc. (Chu-Nan, Miao-Li County, TW) from 2006 to 2018: 13 510(k) clearances. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). Since 2016 its 510(k)s took a median of 122 days from receipt to decision, against 168 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 8 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 Tyson Bioresearch, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2008: 42009: 12011: 12012: 12013: 12017: 12018: 2
2007high 4 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Tyson Bioresearch, Inc.’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?

  • NBWSystem, Test, Blood Glucose, Over The Counter13decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 122 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 168 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 8 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.

  • K052818EZ Smart-168 Glucose Monitoring SystemTyson Bioresearch, Inc. · 20062cite it
  • K170079Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring SystemTyson Bioresearch, Inc. · 20172cite it
  • K090629Easy Step and Diachex+ Pro Blood Glucose Monitoring SystemsTyson Bioresearch, Inc. · 20091cites it
  • K101543Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200Tyson Bioresearch, Inc. · 20111cites it
  • K062829Diachex Blood Glucose Monitoring SystemTyson Bioresearch, Inc. · 20061cites it
  • K073492Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity Blood Glucose Monitoring SystemTyson Bioresearch, Inc. · 20081cites it

What has FDA decided for it lately?

  • K182046Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring SystemTyson Bioresearch, Inc. · 2018
  • K182047Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring SystemTyson Bioresearch, Inc. · 2018
  • K170079Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring SystemTyson Bioresearch, Inc. · 2017
  • K123087Tysonbio AC500, AC800 Blood Glucose Monitoring System, Tysonbio AC500 AC800 Pro Blood Glucose Monitoring…Tyson Bioresearch, Inc. · 2013
  • K112916Tysonbio MD100 Blood Glucse Monitoring ,Tysonbio MD100 Pro Blood Glucise Monitoring SystemTyson Bioresearch, Inc. · 2012
  • K101543Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200Tyson Bioresearch, Inc. · 2011
  • K090629Easy Step and Diachex+ Pro Blood Glucose Monitoring SystemsTyson Bioresearch, Inc. · 2009
  • K081726Tysonbio Link Health Management SystemTyson Bioresearch, Inc. · 2008

All 13 as Tyson Bioresearch, Inc. →