De Novo DEN130010

Device
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
Contact
nancy w bengtson
De Novo number
DEN130010
Product code
PDO
Regulation
864.1870
Classification name
early growth response gene 1 (egr1) fish probe kit for specimen characterization
Decision
granted (DENG)
Decision date
2013-07-29
Date received
2013-04-09
Classification advisory
Hematology
Review advisory
Pathology
Type
Post-NSE

Current FDA Classification#

Product code
PDO
Device name
Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization
Medical specialty
Hematology
Device class
2
Regulation
864.1870
Implant
N
Life sustain/support
N