AXIS-SHIELD ANTI-CCP


Device Classification Name

antibodies, anti-cyclic citrullinated peptide (ccp)

510(k) Number K110296
Device Name AXIS-SHIELD ANTI-CCP
Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
the technology park
luna place
dundee, scotland, 

GB

dd2 1xa

Applicant Contact claire i dora
Correspondent
AXIS-SHIELD DIAGNOSTICS, LTD.
the technology park
luna place
dundee, scotland, 

GB

dd2 1xa

Correspodent Contact claire i dora
Regulation Number 866.5775
Classification Product Code
NHX  
Date Received 02/01/2011
Decision Date 08/18/2011
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