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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
510(k) Number K243410
Device Name simpli-COLLECT STI Test
Applicant
Abbott Molecular
1300 E Touhy Ave
Des Plaines,  IL  60018
Applicant Contact Stacy Ferguson
Correspondent
Abbott Molecular
1300 E Touhy Ave
Des Plaines,  IL  60018
Correspondent Contact Stacy Ferguson
Classification Product Code
QYA  
Date Received11/01/2024
Decision Date 01/30/2025
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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