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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
510(k) Number K243489
Device Name Alinity m EBV (09N43-095)
Applicant
Abbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines,  IL  60018
Applicant Contact Jennifer Peterson
Correspondent
Abbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines,  IL  60018
Correspondent Contact Jennifer Peterson
Regulation Number866.3183
Classification Product Code
QLX  
Subsequent Product Code
OHZ  
Date Received11/12/2024
Decision Date 07/28/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
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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