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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 K222379
Device Name Alinity m STI Assay
Applicant
Abbott Molecular Inc.
1300 E Touhy Ave
Des Plaines,  IL  60018
Applicant Contact Paul Matushek
Correspondent
Abbott Molecular Inc.
1300 E Touhy Ave
Des Plaines,  IL  60018
Correspondent Contact Paul Matushek
Classification Product Code
QEP  
Subsequent Product Codes
LSL   MKZ   OUY  
Date Received08/05/2022
Decision Date 03/03/2023
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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