DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200


Device Classification Name

antibodies, anti-cyclic citrullinated peptide (ccp)

510(k) Number K021516
Device Name DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
Original Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
the technology park
luna place
dundee, scotland, 

GB

dd2 1xa

Original Contact eileen mccafferty
Regulation Number 866.5775
Classification Product Code
NHX  
Date Received 05/10/2002
Decision Date 07/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls