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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name extractable antinuclear antibody, antigen and control
510(k) Number K180975
Device Name QUANTA Flash HMGCR Reagents
Applicant
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131 -1638
Applicant Contact Roger Albesa
Correspondent
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131 -1638
Correspondent Contact Roger Albesa
Regulation Number866.5100
Classification Product Code
LLL  
Date Received04/13/2018
Decision Date 06/25/2018
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
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