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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 K061165
Device Name ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01
Applicant
SWEDEN DIAGNOSTICS (US), INC.
4169 COMMERCIAL AVE.
PORTAGE,  MI  49002
Applicant Contact MARTIN R MANN
Correspondent
SWEDEN DIAGNOSTICS (US), INC.
4169 COMMERCIAL AVE.
PORTAGE,  MI  49002
Correspondent Contact MARTIN R MANN
Regulation Number866.5775
Classification Product Code
NHX  
Date Received04/26/2006
Decision Date 08/03/2006
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
Recalls CDRH Recalls
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