FDA.reportPublic FDA data

De Novo DEN000008

Device
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)
Contact
jonathan s kahan, esq.
De Novo number
DEN000008
Product code
NDS
Regulation
876.5885
Classification name
media, culture, ex vivo, tissue and cell
Decision
granted (DENG)
Decision date
2001-02-16
Date received
2000-12-19
Classification advisory
Gastroenterology/Urology
Review advisory
Gastroenterology/Urology
Type
Post-NSE

Current FDA Classification#

Product code
NDS
Device name
Media, Culture, Ex Vivo, Tissue And Cell
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation
876.5885
Implant
N
Life sustain/support
N