510(k) Report

Devices descending from K070585

9 later devices reach Accu-Chek Performa System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141351Supercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi Blood Glucose…Biotest Medical Corp.20153—
+1K140210Rightest Blood Glucose Monitoring System ( GM720, Rightest Professional BGMS GM720Bionime Corporation20144—
+2K190564Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring…Bionime Corporation20190—
+2K173638Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System…Bionime Corporation20182—
+2K171822NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)Biotest Medical Corporation20170—
+2K171785WowGoHealth Blood Glucose Monitoring SystemBiotest Medical Corporation20171—
+3K231192RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation20241—
+3K213061SuperCheck Pro Blood Glucose Monitoring SystemOk Biotech Co., Ltd.20220—
+4K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation20240—