DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K073492
Device Name DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM
Applicant
TYSON BIORESEARCH, INC.
5 f., # 22, ke tung rd.,
science based industrial park
chun-nan, miao-li county, 

TW

350

Applicant Contact wen-hai tsai
Correspondent
TYSON BIORESEARCH, INC.
5 f., # 22, ke tung rd.,
science based industrial park
chun-nan, miao-li county, 

TW

350

Correspodent Contact wen-hai tsai
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received 12/12/2007
Decision Date 04/08/2008
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