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FDA 510(k) Application Details - K142422
Device Classification Name
More FDA Info for this Device
510(K) Number
K142422
Device Name
cobas Cdiff Test
Applicant
ROCHE MOLECULAR SYSTEMS, INC.
4300 HACIENDA DRIVE
PLEASANTON, CA 94588-2722 US
Other 510(k) Applications for this Company
Contact
Wilk von Gustedt
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OZN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/28/2014
Decision Date
05/20/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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