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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 detection system for non-viral microorganism(s) causing sexually transmitted infections
510(k) Number K202977
Device Name Alinity m STI Assay
Abbott Molecular, Inc.
1300 E. Touhy
Des Plains,  IL  60018
Applicant Contact Stacy Ferguson
Abbott Molecular, Inc.
1300 E. Touhy
Des Plains,  IL  60018
Correspondent Contact Stacy Ferguson
Regulation Number866.3393
Classification Product Code
Subsequent Product Codes
Date Received09/30/2020
Decision Date 04/29/2022
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