AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION


Device Classification Name

glucose oxidase, glucose

510(k) Number K121654
Device Name AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION
Applicant
i-SENS, Inc.
465-6 wolgye-dong, nowon-gu
seoul, 

KR

139-845

Applicant Contact hyun joon oh
Correspondent
i-SENS, Inc.
465-6 wolgye-dong, nowon-gu
seoul, 

KR

139-845

Correspodent Contact hyun joon oh
Regulation Number 862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received 06/05/2012
Decision Date 09/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No