ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5


Device Classification Name

test, epithelial ovarian tumor associated antigen (he4)

510(k) Number K112624
Device Name ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
Applicant
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250 -0416

Applicant Contact jane phillips
Correspondent
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250 -0416

Correspodent Contact jane phillips
Regulation Number 866.6010
Classification Product Code
OIU  
Subsequent Product Codes
JIT   JJX  
Date Received 09/08/2011
Decision Date 09/10/2012
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