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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 K202408
Device Name cobas CTNG for use on cobas 6800/8800 systems
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Drive
pleasanton,  CA  94588 -2722
Applicant Contact aradhana karthikeyan
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Drive
pleasanton,  CA  94588 -2722
Correspondent Contact aradhana karthikeyan
Regulation Number866.3393
Classification Product Code
QEP  
Subsequent Product Codes
LSL   MKZ   OOI  
Date Received08/21/2020
Decision Date 01/21/2021
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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