|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
lightcycler mrsa advanced test for use with the lightcycler 2.0 instrument, model 05205727
|
ROCHE MOLECULAR SYSTEMS, INC.
|
K091409 |
07/06/2010
|
cobas® ct/ng v2.0 test
|
Roche Molecular Systems, Inc.
|
K163184 |
02/09/2017
|
cobas mrsa/sa test
|
ROCHE MOLECULAR SYSTEMS, INC.
|
K142721 |
12/17/2014
|
cobas influenza a/b nucleic acid test for use on the cobas liat system, cobas influenza a/b & rsv nucleic acid test for use on the cobas liat system, cobas strep a nucleic acid test for use on the cobas liat system
|
Roche Molecular Systems, Inc.
|
K200065 |
02/10/2020
|
cobas influenza a/b nucleic acid test for use on the cobas liat system
|
Roche Molecular Systems, Inc.
|
K191729 |
07/24/2019
|
cobas influenza a/b & rsv nucleic acid test for use on the cobas liat system
|
Roche Molecular Systems, Inc.
|
K210234 |
02/16/2021
|
cobas influenza a/b & rsv nucleic acid test for use on the cobas liat system
|
Roche Molecular Systems, Inc.
|
K213822 |
07/06/2022
|
cobas ctng for use on cobas 6800/8800 systems
|
Roche Molecular Systems, Inc.
|
K202408 |
01/21/2021
|
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
|