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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 K070789
Device Name EUROIMMUN ANTI-CCP ELISA
Applicant
Euroimmun Us, LLC
429 Rockaway Valley Rd.
Unit 1200
Boonton Township,  NJ  07005
Applicant Contact KATHRYN KOHL
Correspondent
Euroimmun Us, LLC
429 Rockaway Valley Rd.
Unit 1200
Boonton Township,  NJ  07005
Correspondent Contact KATHRYN KOHL
Regulation Number866.5775
Classification Product Code
NHX  
Date Received03/22/2007
Decision Date 12/31/2007
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
Predetermined Change
Control Plan Authorized		 No
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