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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 K063347
Device Name AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10
Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE, SCOTLAND,  GB DD2 1XA
Applicant Contact ERICA CONWAY
Correspondent
AXIS-SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE, SCOTLAND,  GB DD2 1XA
Correspondent Contact ERICA CONWAY
Regulation Number866.5775
Classification Product Code
NHX  
Subsequent Product Codes
JIX   JJY  
Date Received11/06/2006
Decision Date 03/20/2007
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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