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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Dna Indirect Immunofluorescent Solid Phase
510(k) Number K192916
Device Name NOVA Lite DAPI dsDNA Crithidia luciliae Kit
Applicant
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131
Applicant Contact Carolina Auza
Correspondent
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131
Correspondent Contact Carolina Auza
Regulation Number866.5100
Classification Product Code
KTL  
Subsequent Product Code
PIV  
Date Received10/15/2019
Decision Date 12/11/2020
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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