|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
WEST NILE VIRUS IGM CAPTURE ELISA
|
PANBIO LIMITED |
DEN030004 |
K031703 |
07/08/2003 |
CELLSEARCH EPITHELIAL CELL ENRICHMENT KI
|
ADVANCED DIAGNOSTIC SYSTEMS |
DEN040001 |
K031588 |
01/21/2004 |
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
|
SPECTRAL DIAGNOSTICS, INC. |
DEN030002 |
K021885 |
06/16/2003 |
NIOX ARTICLE NO: 02-1000
|
AEROCRINE AB |
DEN030001 |
K021133 |
04/30/2003 |
RETROX
|
AURIC HEARING SYSTEMS, INC. |
DEN020003 |
K013298 |
08/20/2002 |
BREASTVIEW VISUAL MAPPING SYSTEM
|
ASSURANCE MEDICAL |
DEN020001 |
K010514 |
01/31/2003 |
GIVEN DIAGNOSTIC IMAGING SYSTEM
|
GIVEN IMAGING LTD. |
DEN010002 |
K010312 |
08/01/2001 |
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP)
|
BIOSITE INCORPORATED |
DEN000010 |
K003475 |
11/20/2000 |
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)
|
LIFE TECHNOLOGIES, INC. |
DEN000008 |
K001447 |
02/16/2001 |
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELI
|
INOVA DIAGNOSTICS, INC. |
DEN000007 |
K000732 |
08/16/2000 |