|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
cobas pure integrated solutions, glucose hk gen.3, ise indirect na for gen.2, online dat methadone ii, elecsys tsh
|
Roche Diagnostics
|
K220134 |
09/16/2022
|
glucose hk gen.3, ise indirect na for gen.2, elecsys tsh, cobas pro integrated solutions
|
Roche Diagnostics
|
K191899 |
08/16/2019
|
cobas hba1c test, cobas b 101 system
|
Roche Diagnostics Operations
|
K163633 |
07/28/2017
|
elecsys tsh assay, cobas e 801 immunoassay analyzer
|
ROCHE DIAGNOSTICS
|
K162606 |
01/23/2017
|
cobas c513 analyzer, cobas c13 tina-quant hba1cdx gen.3 assay
|
Roche Diagnostics Operations (RDO)
|
K160571 |
12/19/2016
|
cobas 8000 modular series analyzer
|
ROCHE DIAGNOSTICS CORP.
|
K100853 |
09/09/2010
|
cobas c 111 analyzer
|
Roche Diagnostics
|
K071211 |
07/30/2007
|
cobas 6000 series system
|
Roche Diagnostics
|
K060373 |
03/13/2006
|