BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K002540
Device Name BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS
Original Applicant
BIONOSTICS, INC.
2 craig rd.
acton, 
MA 
01720

Original Contact kathleen storro
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 08/16/2000
Decision Date 09/18/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No