Ok Biotech Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K213061SuperCheck Pro Blood Glucose Monitoring SystemOctober 7, 2022
K162430UniStrip1 Generic Blood Glucose Test StripsJanuary 19, 2017
K160038UniStrip1 Generic Blood Glucose Test StripsJuly 29, 2016
K152599PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring SystemJuly 20, 2016
K142785PRODIGY iConnect Blood Glucose Monitoring SystemDecember 17, 2015
K141914PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEMApril 15, 2015
K132633OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEMAugust 14, 2014
K090609OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEMFebruary 4, 2010
K063026OK METER BLOOD GLUCOSE MONITORING SYSTEMFebruary 9, 2007