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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dna-reagents, neisseria
510(k) Number K231329
Device Name Aptima Neisseria gonorrhoeae Assay
Applicant
Hologic, Inc.
10210 Genetic Center Drive
San Diego,  CA  92121
Applicant Contact Jon Kukowski
Correspondent
Hologic, Inc.
10210 Genetic Center Drive
San Diego,  CA  92121
Correspondent Contact Jon Kukowski
Regulation Number866.3390
Classification Product Code
LSL  
Subsequent Product Code
NSU  
Date Received05/08/2023
Decision Date 01/26/2024
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
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