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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 K240217
Device Name cobas® liat CT/NG nucleic acid test
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton,  CA  94588
Applicant Contact Deborah Leu
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton,  CA  94588
Correspondent Contact Deborah Leu
Classification Product Code
QEP  
Subsequent Product Codes
LSL   MKZ  
Date Received01/26/2024
Decision Date 01/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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