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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Autoantibodies, Nuclear Body Protein, Sp100
510(k) Number K050662
Device Name QUANTA LITE SP100 ELISA
Applicant
Inova Diagnostics, Inc.
10180 Scripps Ranch Blvd.
San Diego,  CA  92131
Applicant Contact GARY L NORMAN
Correspondent
Inova Diagnostics, Inc.
10180 Scripps Ranch Blvd.
San Diego,  CA  92131
Correspondent Contact GARY L NORMAN
Regulation Number866.5090
Classification Product Code
NUM  
Date Received03/15/2005
Decision Date 06/13/2005
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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