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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 K052264
Device Name QUANTA LITE CCP3 IGG ELISA
Applicant
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131 -1638
Applicant Contact BRYS C MYERS
Correspondent
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131 -1638
Correspondent Contact BRYS C MYERS
Regulation Number866.5775
Classification Product Code
NHX  
Date Received08/19/2005
Decision Date 11/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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