|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
cobas 4800 ct / ng test
|
ROCHE MOLECULAR SYSTEMS, INC.
|
K110923 |
01/24/2012
|
cobas cdiff nucleic acid test for use on the cobas liat system
|
Roche Molecular Systems, Inc.
|
K171770 |
09/12/2017
|
cobas cdiff nucleic acid test for use on the cobas liat system
|
Roche Molecular Systems, Inc.
|
K210385 |
09/09/2021
|
cobas cdiff nucleic acid test for use on the cobas liat system
|
Roche Molecular Systems, Inc.
|
K212427 |
10/20/2021
|
cobas cdiff test
|
ROCHE MOLECULAR SYSTEMS, INC.
|
K142422 |
05/20/2015
|
cobas ct/ng for use on cobas 6800/8800 systems
|
Roche Molecular Systems, Inc.
|
K173887 |
03/21/2018
|
cobas ct/ng v2.0 test
|
ROCHE MOLECULAR SYSTEMS, INC.
|
K132270 |
12/02/2013
|
cobas ct/ng v2.0 test
|
ROCHE MOLECULAR SYSTEMS, INC.
|
K140887 |
05/05/2014
|
cobas ctng for use on cobas 6800/8800 systems
|
Roche Molecular Systems, Inc.
|
K202408 |
01/21/2021
|
cobas influenza a/b & rsv nucleic acid test for use on the cobas liat system
|
Roche Molecular Systems, Inc.
|
K210234 |
02/16/2021
|