Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K171770
Device Classification Name
More FDA Info for this Device
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 Drive
Pleasanton, CA 94588-2722 US
Other 510(k) Applications for this Company
Contact
Clare Santulli
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
06/14/2017
Decision Date
09/12/2017
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact