FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K103450
Device Name FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE
Applicant
FUJIREBIO DIAGNOSTICS, INC
940 crossroads blvd.
seguin, 
TX 
78155

Applicant Contact kent pruett
Correspondent
FUJIREBIO DIAGNOSTICS, INC
940 crossroads blvd.
seguin, 
TX 
78155

Correspodent Contact kent pruett
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 11/24/2010
Decision Date 01/25/2011
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