|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
VYSIS AUTOVYSION SYSTEM
|
VYSIS |
DEN040010 |
K041875 |
12/13/2004 |
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L
|
WAKO CHEMICALS, USA, INC. |
DEN050002 |
K041847 |
05/19/2005 |
DECAPINOL ORAL RINSE
|
SINCLAIR PHARMACEUTICALS LIMITED |
DEN050001 |
K041482 |
04/18/2005 |
HAMILTON THORNE ZONA INFRARED LASER OPTI
|
HAMILTON THORNE BIOSCIENCES |
DEN040009 |
K040045 |
11/04/2004 |
CEDIA SIROLIMUS ASSAY
|
MICROGENICS CORP. |
DEN040008 |
K034069 |
07/28/2004 |
FACTOR V LEIDEN KIT
|
ROCHE DIAGNOSTICS CORP. |
DEN030005 |
K033607 |
12/17/2003 |
VERICHIP HEALTH INFORMATION MICROTRANSPO
|
DIGITAL ANGEL CORPORATION |
DEN040007 |
K033440 |
10/12/2004 |
CELLERATION MIST THERAPY SYSTEM
|
CELLERATION |
DEN040004 |
K032378 |
06/25/2004 |
GLUCATELL
|
ASSOCIATES OF CAPE COD, INC. |
DEN040003 |
K032373 |
05/21/2004 |
NEOGRAM AMINO ACIDS AND ACYLCARNITINES T
|
PERKINELMER LIFE SCIENCES, INC. |
DEN040002 |
K031878 |
08/24/2004 |