ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

glucose oxidase, glucose

510(k) Number K011479
Device Name ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
INVERNESS MEDICAL INNOVATIONS, INC.
51 sawyer rd., suite 200
waltham, 
MA 
02453 -3448

Original Contact carol a adiletto
Regulation Number 862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received 05/14/2001
Decision Date 11/30/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No