EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM


Device Classification Name

glucose dehydrogenase, glucose

510(k) Number K121207
Device Name EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
Applicant
EPS BIO TECHNOLOGY CORP.
no.8 r&d rd iii
hsinchu science park
hsinchu city,, 

TW

30077

Applicant Contact cynthia hung
Correspondent
EPS BIO TECHNOLOGY CORP.
no.8 r&d rd iii
hsinchu science park
hsinchu city,, 

TW

30077

Correspodent Contact cynthia hung
Regulation Number 862.1345
Classification Product Code
LFR  
Subsequent Product Codes
JJX   NBW  
Date Received 04/20/2012
Decision Date 05/18/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No