ELECSYS ANTI-TSHR CALCHECK


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K080643
Device Name ELECSYS ANTI-TSHR CALCHECK
Applicant
Roche Diagnostics
9115 hague rd.
indianapolis, 
IN 
46250

Applicant Contact stephanie greeman
Correspondent
Roche Diagnostics
9115 hague rd.
indianapolis, 
IN 
46250

Correspodent Contact stephanie greeman
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 03/06/2008
Decision Date 08/22/2008
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