ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB


Device Classification Name

system, test, thyroid autoantibody

510(k) Number K080092
Device Name ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd. bx 50416
indianapolis, 
IN 
46250 -0416

Applicant Contact stephanie greeman
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 hague rd. bx 50416
indianapolis, 
IN 
46250 -0416

Correspodent Contact stephanie greeman
Regulation Number 866.5870
Classification Product Code
JZO  
Subsequent Product Code
JJX  
Date Received 01/14/2008
Decision Date 07/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No