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Tyson Bioresearch, Inc.

FDA Regulatory Profile

Tyson Bioresearch, Inc. has 0 FDA recalls, 3 inspections, 13 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 5, 2024 · VAI
Latest 510(k)
Nov 30, 2018

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances13Oct 4, 2026Not statedCurrent
Inspections3Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 5, 2024Miaoli County, TaiwanDevicesVoluntary Action Indicated (VAI)3003132490
Mar 23, 2017Miaoli County, TaiwanDevicesVoluntary Action Indicated (VAI)3003132490
Apr 30, 2015Miaoli County, TaiwanDevicesVoluntary Action Indicated (VAI)3003132490

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K182046Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring SystemNov 30, 2018
K182047Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring SystemNov 29, 2018
K170079Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring SystemOct 6, 2017
K123087TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE…Jun 18, 2013
K112916TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEMAug 21, 2012
K101543TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200Aug 30, 2011
K090629EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMSJun 4, 2009
K081726TYSONBIO LINK HEALTH MANAGEMENT SYSTEMAug 26, 2008
K072854DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEMJun 30, 2008
K073492DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEMApr 8, 2008
K072441EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEMMar 25, 2008
K062829DIACHEX BLOOD GLUCOSE MONITORING SYSTEMOct 10, 2006
K052818EZ SMART-168 GLUCOSE MONITORING SYSTEMJun 16, 2006

FDA data resources