PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K080960
Device Name PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS
Applicant
ABBOTT DIABETES CARE INC.
1360 south loop rd.
alameda, 
CA 
94502

Applicant Contact tammy wharton
Correspondent
ABBOTT DIABETES CARE INC.
1360 south loop rd.
alameda, 
CA 
94502

Correspodent Contact tammy wharton
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JIN   LFR  
Date Received 04/03/2008
Decision Date 09/05/2008
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