Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM

K-Number: K112916 · 2012-08-21

ApplicantTyson Bioresearch, Inc.
Decision Date2012-08-21
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tyson Bioresearch, Inc.. It received FDA 510(k) clearance on 2012-08-21 under 510(k) number K112916. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM?

TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2012-08-21. The listed applicant is Tyson Bioresearch, Inc.. The 510(k) number is K112916.

When did TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM receive FDA 510(k) clearance?

TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM received FDA 510(k) clearance on 2012-08-21, under 510(k) number K112916.

Who is the listed applicant for TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM?

The FDA 510(k) record lists Tyson Bioresearch, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM?

The FDA product code for TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM is NBW. This falls under the OB/GYN category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tyson Bioresearch, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182046Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring SystemK182047Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring SystemK170079Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring SystemK123087TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEMK101543TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200K090629EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS

View all 13 devices →

Related Devices (Code: NBW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes CareK262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime CorporationK240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑