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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 K090753
Device Name THERATEST EL-ANTI-CCP/2
Applicant
Theratest Laboratories, Inc.
1111 N. Main St.
Lombard,  IL  60148
Applicant Contact MARIUS TEODORESCU
Correspondent
Theratest Laboratories, Inc.
1111 N. Main St.
Lombard,  IL  60148
Correspondent Contact MARIUS TEODORESCU
Regulation Number866.5775
Classification Product Code
NHX  
Date Received03/20/2009
Decision Date 03/05/2010
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
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