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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
510(k) Number K052262
Device Name QUANTA LITE M2 EP (MIT3) ELISA
Applicant
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131
Applicant Contact BRYS C MYERS
Correspondent
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131
Correspondent Contact BRYS C MYERS
Regulation Number866.5090
Classification Product Code
DBM  
Date Received08/19/2005
Decision Date 10/27/2005
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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