DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K122307
Device Name DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM
Applicant
BIOCARE CORPORATION
4f, no.12, lane 5, sec. 2
nashan rd lujihu township
taoyuan county, 

TW

33852

Applicant Contact shuchi chang
Correspondent
BIOCARE CORPORATION
4f, no.12, lane 5, sec. 2
nashan rd lujihu township
taoyuan county, 

TW

33852

Correspodent Contact shuchi chang
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received 08/01/2012
Decision Date 04/05/2013
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