510(k) K182047

Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System by Tyson Bioresearch, Inc. — Product Code NBW

K182047 is an FDA 510(k) premarket notification submitted by Tyson Bioresearch, Inc. for the device "Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on Nov 29, 2018. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Tyson Bioresearch, Inc. has 12 other 510(k) clearances on record.