Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003132490

FEI Number

3003132490

Entity Name

TYSON BIORESEARCH, INC.

City/State/Country

Zhunan Township Miaoli, TW

Establishment Address

5F., No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township Miaoli 35053, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TYSON BIORESEARCH, INC. (Owner Number: 9047348)

Owner / Operator Contact Address

5F., No. 16, 18, 20, 22, Kedong 3rd Rd.,, Zhunan Township, Miaoli County, TW-NOTA 35053, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K073492

PMA Number

N/A

All Registered Proprietary Names

TysonBio AC200 Blood Glucose Monitoring System Tyson Bio HT100-B Blood Glucose Monitoring System Tyson Bio HT100 Blood Glucose Monitoring System Glucomate HT100 Blood Glucose Monitoring System TysonBio AC500 Blood Glucose Monitoring System ONE-CARE PRO (Model AC500 PRO) Blood Glucose Monitoring System ONE-CARE (Model AC500) Blood Glucose Monitoring System TysonBio AC500 PRO Blood Glucose Monitoring System TysonBio Evolve Blood Glucose Monitoring System Easy Touch Blood Glucose Monitoring System Easy Touch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-11-07
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-11-07
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2018-03-23
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2017-11-16
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2017-11-16
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-11-16
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2008-05-08
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2008-05-08

Official Correspondent

No official correspondent registered.

US Agent Details

David Lee Business: Dynamic Biotech, Inc. Email: davidlee@ivddreg.com Phone: (949) 2180929

Related Public Records

Same Entity

TYSON BIORESEARCH, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150396	Apex BioTechnology Corp.	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14
K150833	Andon Health Co, Ltd.	iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System	2015-12-04
K811074	Reagents Applications, Inc.	GLUCOSE REAGENT-ENZYMATIC-COLOR 500	1981-04-29
K936212	Heraeus Kulzer, Inc.	GLUCOFILM TEST STRIPS	1994-05-10
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06	Abbott Laboratories Medisense Products	2	Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000

Similar Registrations

Registration Number	Establishment Name	Location
3005706626	Bioptik Technology, Inc.	Jhunan Township Miaoli, TW
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3014302067	MICROTECH MEDICAL (HANGZHOU) CO., LTD.	Hangzhou Zhejiang, CN
3014353121	VIDAN DIAGNOSTICS, LLC	San Antonio, TX, US
3008514395	Telcare, LLC	Linwood, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003132490. Last updated year: 2026. Please use registration number 3003132490 when referencing this establishment in official correspondence.