510(k) Report

Devices descending from K000318

11 later devices reach Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022769Lifescan Onetouch Ultra Control SolutionBionostics, Inc.20029—
+1K013147Glucose Control Solution for Therasense FreestyleBionostics, Inc.200101
+2K160179VivaChek Ino Blood Glucose Monitoring SystemVivachek Laboratories, Inc.20174—
+2K111456Medisign Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd.20122—
+2K103553Lifescan Onetouch Select / Ultra / Vita Glucose Control SolutionBionostics, Inc.20110—
+3K173140VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose…Vivachek Laboratories, Inc.20183—
+3K152534Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose…Tianjin Empecs Medical Device Co., Ltd.20170—
+3K133260Medisign Blood Glucse Monitoring System, Medisign Multi Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd.20140—
+4K233058VivaChek Link Plus Blood Glucose Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd.20231—
+4K223722MIO Blood Glucose Monitoring SystemMio Labs, Inc.20230—
+5K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.20250—