DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K103329
Device Name DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION
Applicant
DELBIO INCORPORATION
252, shangying road
guishan industrial zone
taoyuan county, 

TW

33341

Applicant Contact nicky pan
Correspondent
DELBIO INCORPORATION
252, shangying road
guishan industrial zone
taoyuan county, 

TW

33341

Correspodent Contact nicky pan
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received 11/12/2010
Decision Date 03/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No