LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K022769
Device Name LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION
Original Applicant
BIONOSTICS, INC.
7 jackson rd.
devens, 
MA 
01432

Original Contact kathleen storro
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 08/21/2002
Decision Date 11/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No