AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K080273
Device Name AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION
Applicant
FUJIREBIO DIAGNOSTICS TEXAS, INC.
940 crossroads blvd.
seguin, 
TX 
78155

Applicant Contact john gormley
Correspondent
FUJIREBIO DIAGNOSTICS TEXAS, INC.
940 crossroads blvd.
seguin, 
TX 
78155

Correspodent Contact john gormley
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 02/01/2008
Decision Date 08/08/2008
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