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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name c. difficile toxin gene amplification assay
510(k) Number K212427
Device Name cobas Cdiff nucleic acid test for use on the cobas Liat System
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton,  CA  94588 -2722
Applicant Contact Kaitlyn Hameister
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton,  CA  94588 -2722
Correspondent Contact Kaitlyn Hameister
Regulation Number866.3130
Classification Product Code
OZN  
Subsequent Product Code
OOI  
Date Received08/04/2021
Decision Date 10/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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