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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