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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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