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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 K213403
Device Name Aptiva CTD Essential Reagent
Applicant
Inova Diagnostics, Inc.
9900 Old Grove Road
San Diego,  CA  92131
Applicant Contact Andrea Seaman
Correspondent
Inova Diagnostics, Inc.
9900 Old Grove Road
San Diego,  CA  92131
Correspondent Contact Andrea Seaman
Regulation Number866.5100
Classification Product Code
LLL  
Subsequent Product Codes
LJM   LKO   LKP   LSW   MQA  
OBE  
Date Received10/18/2021
Decision Date 09/29/2023
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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