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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
510(k) Number K233349
Device Name Alinity m HSV 1 & 2 / VZV
Applicant
Abbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines,  IL  60018
Applicant Contact Stacy Ferguson
Correspondent
Abbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines,  IL  60018
Correspondent Contact Stacy Ferguson
Regulation Number866.3309
Classification Product Code
PGI  
Date Received09/29/2023
Decision Date 05/03/2024
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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