|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
X-RAY ATTENUATING CREAM
|
BLOXR CORPORATION |
DEN120022 |
K123422 |
05/09/2013 |
GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY
|
GIVEN IMAGING LTD. |
DEN120023 |
K123666 |
01/29/2014 |
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
|
Roche Diagnostics |
DEN130002 |
K121291 |
05/23/2013 |
XTAG GASTROINTESTINAL PATHOGEN PANEL (GP
|
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
DEN130003 |
K121454 |
01/14/2013 |
MOERAE SURGICAL MARKING PEN
|
MOERAE MATRIX, INC. |
DEN130004 |
|
12/18/2014 |
QUANTITATION OF ORGANOPHOSPHATE METABOL
|
CENTERS FOR DISEASE CONTROL AND PREVENTI |
DEN130005 |
K122282 |
08/08/2013 |
AXIOS STENT AND DELIVERY SYSTEM
|
XLUMENA, INC |
DEN130007 |
K123250 |
12/18/2013 |
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN
|
ABBOTT MOLECULAR, INC. |
DEN130010 |
K123951 |
07/29/2013 |
ILLUMINA MISEQDX PLATFORM
|
ILLUMINA, INC. |
DEN130011 |
K123989 |
11/19/2013 |
FERRISCAN R2-MRI ANALYSIS SYSTEM
|
RESONANCE HEALTH ANALYSIS SERVICES PTY L |
DEN130012 |
K124065 |
01/23/2013 |