HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K110074
Device Name HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM
Applicant
HEALTH & LIFE CO., LTD.
9f, no.186, jian yi road
chung ho city, taipei, 

TW

235

Applicant Contact sarah su
Correspondent
HEALTH & LIFE CO., LTD.
9f, no.186, jian yi road
chung ho city, taipei, 

TW

235

Correspodent Contact sarah su
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received 01/10/2011
Decision Date 05/25/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No