|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
MANDOMETER III
|
AB MANDO |
DEN070014 |
K063817 |
03/31/2011 |
ID-TAG RESPIRATORY VIRAL PANEL
|
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
DEN070013 |
K063765 |
01/03/2008 |
MAMMAPRINT
|
AGENDIA BV |
DEN070009 |
K062694 |
02/06/2007 |
3M N95 HOME RESPIRATOR WITH FLUID RESIST
|
3M COMPANY |
DEN060009 |
K062070 |
05/08/2007 |
BINAX NOW MALARIA TEST; MODEL 660-000, 6
|
INVERNESS MEDICAL PROFESSIONAL DIAGNOSTI |
DEN070006 |
K061542 |
06/13/2007 |
XPERT EV, MODEL GXEV-100N-10; GENEXPERT
|
CEPHEID |
DEN070004 |
K061062 |
03/16/2007 |
NEUROSTAR TMS SYSTEM
|
NEURONETICS |
DEN070003 |
K061053 |
10/07/2008 |
QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE D
|
QUICK-MED TECHNOLOGIES, INC. |
DEN070002 |
K060662 |
02/25/2009 |
INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REA
|
CENTERS FOR DISEASE CONTROL AND PREVENTI |
DEN060008 |
K060159 |
02/03/2006 |
INTROL CF PANEL I CONTROL
|
MAINE MOLECULAR QUALITY CONTROLS, INC. |
DEN060007 |
K060070 |
10/12/2006 |