GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K081403
Device Name GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK
Applicant
BIONOSTICS, INC.
7 jackson rd.
devens, 
MA 
01434

Applicant Contact randy byrd
Correspondent
BIONOSTICS, INC.
7 jackson rd.
devens, 
MA 
01434

Correspodent Contact randy byrd
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 05/19/2008
Decision Date 07/25/2008
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