|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
PAXGENE BLOOD RNA SYSTEM
|
PREANALYTIX GMBH |
DEN050003 |
K042613 |
04/18/2005 |
DECAPINOL ORAL RINSE
|
SINCLAIR PHARMACEUTICALS LIMITED |
DEN050001 |
K041482 |
04/18/2005 |
TAG-IT CYSTIC FIBROSIS KIT
|
TM BIOSCIENCE CORPORATION |
DEN050004 |
K043011 |
05/09/2005 |
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L
|
WAKO CHEMICALS, USA, INC. |
DEN050002 |
K041847 |
05/19/2005 |
CARDIOMEMS ENDOSENSOR WITH DELIVERY SYST
|
CARDIOMEMS INC |
DEN050006 |
K050939 |
10/28/2005 |
INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REA
|
CENTERS FOR DISEASE CONTROL AND PREVENTI |
DEN060008 |
K060159 |
02/03/2006 |
HEALTHCHECK(TM) HOME TEST FOR LOSS OF TH
|
FMG INNOVATIONS, INC. |
DEN050007 |
K051653 |
03/27/2006 |
PHICAL TEST
|
GENOVA DIAGNOSTICS |
DEN060001 |
K050007 |
04/26/2006 |
INTROL CF PANEL I CONTROL
|
MAINE MOLECULAR QUALITY CONTROLS, INC. |
DEN060007 |
K060070 |
10/12/2006 |
Sepax Cell Separation System and Single
|
Biosafe SA |
|
BK060036 |
01/03/2007 |