|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
XTAG GASTROINTESTINAL PATHOGEN PANEL (GP
|
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
DEN130003 |
K121454 |
01/14/2013 |
FERRISCAN R2-MRI ANALYSIS SYSTEM
|
RESONANCE HEALTH ANALYSIS SERVICES PTY L |
DEN130012 |
K124065 |
01/23/2013 |
X-RAY ATTENUATING CREAM
|
BLOXR CORPORATION |
DEN120022 |
K123422 |
05/09/2013 |
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
|
Roche Diagnostics |
DEN130002 |
K121291 |
05/23/2013 |
CABOCHON SYSTEM
|
CABOCHON AESTHETICS, INC. |
DEN110004 |
K101231 |
07/12/2013 |
VERIFY CRONOS SELF-CONTAINED BIOLOGICAL
|
STERIS Corporation |
DEN110006 |
K102469 |
07/12/2013 |
NEBA SYSTEM
|
LEXICOR MEDICAL TECHNOLOGY, LLC |
DEN110019 |
K112711 |
07/15/2013 |
XPERT MTB/RIF ASSAY
|
CEPHEID |
DEN130032 |
K131706 |
07/25/2013 |
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN
|
ABBOTT MOLECULAR, INC. |
DEN130010 |
K123951 |
07/29/2013 |
QUANTITATION OF ORGANOPHOSPHATE METABOL
|
CENTERS FOR DISEASE CONTROL AND PREVENTI |
DEN130005 |
K122282 |
08/08/2013 |