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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 K142422
Device Name cobas Cdiff Test
Applicant
ROCHE MOLECULAR SYSTEMS, INC.
4300 HACIENDA DRIVE
PLEASANTON,  CA  94588 -2722
Applicant Contact Wilk von Gustedt
Correspondent
ROCHE MOLECULAR SYSTEMS, INC.
4300 HACIENDA DRIVE
PLEASANTON,  CA  94588 -2722
Correspondent Contact David W. Gates
Regulation Number866.3130
Classification Product Code
OZN  
Subsequent Product Code
OOI  
Date Received08/28/2014
Decision Date 05/20/2015
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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