GLUCOSE CONTROL SOLUTION FOR BD LATITUDE


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K021697
Device Name GLUCOSE CONTROL SOLUTION FOR BD LATITUDE
Original Applicant
BIONOSTICS, INC.
7 jackson rd.
devens, 
MA 
01432

Original Contact kathleen storro
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 05/22/2002
Decision Date 07/12/2002
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