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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name antibodies, anti-cyclic citrullinated peptide (ccp)
510(k) Number K083868
Device Name ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE, SCOTLAND,  GB DD2 1XA
Applicant Contact Claire Dora
Correspondent
AXIS-SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE, SCOTLAND,  GB DD2 1XA
Correspondent Contact Claire Dora
Regulation Number866.5775
Classification Product Code
NHX  
Subsequent Product Codes
JIX   JJY  
Date Received12/29/2008
Decision Date 09/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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