Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System— 510(k) K170079

Clearance details

Applicant

Tyson Bioresearch, Inc.

Product code

Code NBW

Device class

Class 2

Regulation

21 CFR 862.1345

Advisory panel

Clinical Chemistry

Date received

2017-01-10

Decision date

2017-10-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Chu-Nan, Miao-Li County, TW

• K260545 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System +2 more2026-08-27
• K262116 — TRUE METRIX Self Monitoring Blood Glucose System2026-07-23
• K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System +1 more2025-10-10
• K243060 — TeleRPM Gen2 Blood Glucose Monitoring System2025-01-30
• K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel2024-11-04

• K182046 — Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System2018-11-30
• K182047 — Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System2018-11-29
• K123087 — TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM2013-06-18
• K112916 — TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM2012-08-21
• K101543 — TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC2002011-08-30

Death

18

Injury

4,740

Malfunction

42,679

Other

6

Total

47,443

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →