EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM


Device Classification Name

glucose dehydrogenase, glucose

510(k) Number K112272
Device Name EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
Applicant
EPS BIO TECHNOLOGY CORP.
no.8 r&d rd iii
hsinchu science park
hsinchu city, hsinchu, 

TW

30077

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

TW

30077

Correspodent Contact yc lei
Regulation Number 862.1345
Classification Product Code
LFR  
Subsequent Product Codes
JJX   NBW  
Date Received 08/08/2011
Decision Date 09/07/2011
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