FDA 510(k) Application Details - K212427

Device Classification Name	More FDA Info for this Device
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 US Other 510(k) Applications for this Company
Contact	Kaitlyn Hameister 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	08/04/2021
Decision Date	10/20/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review