De Novo DEN230085

Device
VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator
Contact
anthony piotrkowski
De Novo number
DEN230085
Product code
SDC
Regulation
880.6930
Classification name
qualitative cleaning process protein indicator
Decision
granted (DENG)
Decision date
2024-11-12
Date received
2023-12-18
Classification advisory
General Hospital
Review advisory
General Hospital
Type
Direct

Current FDA Classification#

Product code
SDC
Device name
Qualitative Cleaning Process Protein Indicator
Medical specialty
General Hospital
Device class
2
Regulation
880.6930
Implant
N
Life sustain/support
N