FDA.reportPublic FDA data

De Novo DEN130031

Device
NEPHROCHECK TEST SYSTEM
Contact
karin hughes
De Novo number
DEN130031
Product code
PIG
Regulation
862.1220
Classification name
acute kidney injury test system
Decision
granted (DENG)
Decision date
2014-09-05
Date received
2013-06-05
Classification advisory
Clinical Chemistry
Review advisory
Clinical Chemistry
Type
Direct

Current FDA Classification#

Product code
PIG
Device name
Acute Kidney Injury Test System
Medical specialty
Clinical Chemistry
Device class
2
Regulation
862.1220
Implant
N
Life sustain/support
N