|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
QUANTITATION OF ORGANOPHOSPHATE METABOL
|
CENTERS FOR DISEASE CONTROL AND PREVENTI |
DEN130005 |
K122282 |
08/08/2013 |
XTAG GASTROINTESTINAL PATHOGEN PANEL (GP
|
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
DEN130003 |
K121454 |
01/14/2013 |
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
|
Roche Diagnostics |
DEN130002 |
K121291 |
05/23/2013 |
DEKA ARM SYSTEM
|
DEKA INTEGRATED SOLUTIONS CORPORATION |
DEN120016 |
K121215 |
05/09/2014 |
EEVA 2.0
|
AUXOGYN, INC. |
DEN120015 |
K120427 |
06/06/2014 |
VERIGENE GRAM POSITIVE BLOOD CULTURE NUC
|
NANOSPHERE, INC |
DEN120014 |
K113450 |
06/26/2012 |
PORTRAIT ANALYZER
|
GREAT BASIN SCIENTIFIC |
DEN120013 |
K113358 |
04/30/2012 |
CDC DENV-1-4 REAL TIME RT-PCT ASSAY
|
CENTERS FOR DISEASE CONTROL AND PREVENTI |
DEN120012 |
K113336 |
05/24/2012 |
PROTEUS INGESTION CONFINMATION SYSTEMS
|
PROTEUS BIOMEDICAL, INC. |
DEN120011 |
K113070 |
07/10/2012 |
NEBA SYSTEM
|
LEXICOR MEDICAL TECHNOLOGY, LLC |
DEN110019 |
K112711 |
07/15/2013 |