ELECSYS PRECICONTROL VARIA 3


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K111506
Device Name ELECSYS PRECICONTROL VARIA 3
Applicant
Roche Diagnostics
9115 hague road
p.o. box 50410
indianapolis, 
IN 
46250 -0416

Applicant Contact sarah baumann
Correspondent
Roche Diagnostics
9115 hague road
p.o. box 50410
indianapolis, 
IN 
46250 -0416

Correspodent Contact sarah baumann
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 06/01/2011
Decision Date 07/08/2011
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