510(k) Report

Devices descending from K060467

17 later devices reach Prodigy Blood Glucose Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160038UniStrip1 Generic Blood Glucose Test StripsOk Biotech Co., Ltd.20161—
+1K073118Prodigy Voice Blood Glucose Monitoring SystemDiagnostic Devices, Inc.200814—
+2K162430UniStrip1 Generic Blood Glucose Test StripsOk Biotech Co., Ltd.20170—
+2K122340Prodigy ChoiceProdigy Diabetes Care, LLC20130—
+2K122338Preferred Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC20133—
+2K090609Okmeter Match Blood Glucose Monitoring SystemOk Biotech Co., Ltd.20101—
+2K091815Supercheck 1 Blood Glucose Monitoring System, Model 6268Biotest Medical Corp.20096—
+3K142785PRODIGY iConnect Blood Glucose Monitoring SystemOk Biotech Co., Ltd.20150—
+3K141914Prodigy Autocode Eject Blood Glucose Monitoring SystemOk Biotech Co., Ltd.20151—
+3K132633Okmeter Direct Blood Glucose Monitoring SystemOk Biotech Co., Ltd.20140—
+3K122525Smartest Glucowise Blood Glucose Monitoring System, and Smartest Glucoswise Multi Blood…Biotest Medical Corp.20130—
+3K100560Easy Talk Blood Glucose Monitoring System Model: 6277Biotest Medical Corp.20101—
+3K100701Smartest Persona Blood Glucose Test Sytem Model: 6277Biotest Medical Corp.20100—
+3K093764SOLOV2 Blood Glucose Monitoring SystemBiotest Medical Corp.20101—
+4K152599PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose…Ok Biotech Co., Ltd.20160—
+4K133509Easy Plus II Blood Glucose Monitoring System,Easy Plus II Multi Blood Glucose Monitoring…Biotest Medical Corp.20140—
+4K123559Solusmobile Blood Glucose Managment SystemBiotest Medical Corp.20130—