Data / Medical devices / Taiwan / Tyson Bioresearch, Inc.
Tyson Bioresearch, Inc.: FDA-registered device maker in Zhunan Township Miaoli, Taiwan, 5 510(k) clearances
Tyson Bioresearch, Inc. is registered with the FDA (registration 3003132490) in Zhunan Township Miaoli, Taiwan. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 30, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003132490
- Address
- 5F., No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township Miaoli, Taiwan, 35053
- Owner or operator
- TYSON BIORESEARCH, INC. (9047348)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- May 8, 2008
- Registered through
- 2026
- Brand names listed
- Easy Touch, Easy Touch Blood Glucose Monitoring System, GLUCO-CARE HS100 Blood Glucose Monitoring System, Genteel HS100 Blood Glucose Monitoring System, Glucomate HT100 Blood Glucose Monitoring System, ONE-CARE (Model AC500) Blood Glucose Monitoring System, ONE-CARE PRO (Model AC500 PRO) Blood Glucose Monitoring System, Tyson Bio HS100 Blood Glucose Monitoring System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 30, 2018 | K182046 | Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System | NBW | Substantially Equivalent | Tyson Bioresearch, Inc. | accessdata.fda.gov |
| October 6, 2017 | K170079 | Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System | NBW | Substantially Equivalent | Tyson Bioresearch, Inc. | accessdata.fda.gov |
| June 18, 2013 | K123087 | TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Tyson Bioresearch, Inc. | accessdata.fda.gov |
| August 30, 2011 | K101543 | TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200 | NBW | Substantially Equivalent | Tyson Bioresearch, Inc. | accessdata.fda.gov |
| April 8, 2008 | K073492 | DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Tyson Bioresearch, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Glucose Oxidase, Glucose
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
Updated November 30, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.