ELECSYS T4 CALCHECK 5


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K112528
Device Name ELECSYS T4 CALCHECK 5
Applicant
ROCHE DIAGNOSTICS CORPORATION
9115 hague road
po box 50416
indianapolis, 
IN 
46250 -0416

Applicant Contact michael leuther
Correspondent
ROCHE DIAGNOSTICS CORPORATION
9115 hague road
po box 50416
indianapolis, 
IN 
46250 -0416

Correspodent Contact michael leuther
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 08/31/2011
Decision Date 10/18/2011
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