ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP


Device Classification Name

antibodies, anti-cyclic citrullinated peptide (ccp)

510(k) Number K081338
Device Name ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP
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 866.5775
Classification Product Code
NHX  
Subsequent Product Code
JJX  
Date Received 05/13/2008
Decision Date 09/11/2008
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