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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 K212778
Device Name Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)
Applicant
Abbott Molecular, Inc.
1300 E. Touhy Ave
Des Plaines,  IL  60018
Applicant Contact Gina Sammarco
Correspondent
Abbott Molecular, Inc.
1300 E. Touhy Ave
Des Plaines,  IL  60018
Correspondent Contact Gina Sammarco
Regulation Number866.3183
Classification Product Code
QLX  
Date Received09/01/2021
Decision Date 07/15/2022
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
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