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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
510(k) Number K243979
Device Name Aptiva APS IgA Reagent
Applicant
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131
Applicant Contact Melissa Sanchez
Correspondent
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131
Correspondent Contact Constance Bridges
Regulation Number866.5660
Classification Product Code
MSV  
Subsequent Product Code
MID  
Date Received12/23/2024
Decision Date 02/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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