TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K110571
Device Name TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE
Applicant
TELCARE, INC.
3 bethesda metro center
suite 430
bethesda, 
MD 
20814

Applicant Contact jonathan c javitt
Correspondent
TELCARE, INC.
3 bethesda metro center
suite 430
bethesda, 
MD 
20814

Correspodent Contact jonathan c javitt
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX   JQP  
Date Received 03/01/2011
Decision Date 07/28/2011
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