Tyson Bioresearch, Inc.
Zhunan Township Miaoli, TW
TYSON BIORESEARCH, INC. appears in FDA device records in Zhunan Township Miaoli, TW. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Tyson Bioresearch, Inc. between 2006 and 2018. The busiest year on record is 2008, with 4. The most recent is 2018, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 2 |
| 2008 | 4 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K182046 | Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K182047 | Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K170079 | Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K123087 | TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K112916 | TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K101543 | TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200 | NBW | Substantially Equivalent | |
| K090629 | EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS | NBW | Substantially Equivalent | |
| K081726 | TYSONBIO LINK HEALTH MANAGEMENT SYSTEM | NBW | Substantially Equivalent | |
| K072854 | DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K073492 | DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K072441 | EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K062829 | DIACHEX BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K052818 | EZ SMART-168 GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003132490 | 3003132490 | TYSON BIORESEARCH, INC. | 5F., No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township Miaoli 35053 TW | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain