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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 K171770
Device Name cobas Cdiff Nucleic acid test for use on the cobas Liat System
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton,  CA  94588 -2722
Applicant Contact Clare Santulli
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton,  CA  94588 -2722
Correspondent Contact Clare Santulli
Regulation Number866.3130
Classification Product Code
OZN  
Subsequent Product Code
OOI  
Date Received06/14/2017
Decision Date 09/12/2017
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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