Skip to contentDe Novo DEN200062
- Device
- Parsortix PC1 Device
- Contact
- andrew newland
- De Novo number
- DEN200062
- Product code
- QSA
- Regulation
- 866.6110
- Classification name
- circulating tumor cell (ctc) enrichment device
- Decision
- granted (DENG)
- Decision date
- 2022-05-24
- Date received
- 2020-09-28
- Classification advisory
- Immunology
- Review advisory
- Molecular Genetics
- Type
- Direct
Current FDA Classification#
- Product code
- QSA
- Device name
- Circulating Tumor Cell (Ctc) Enrichment Device
- Medical specialty
- Immunology
- Device class
- 2
- Regulation
- 866.6110
- Implant
- N
- Life sustain/support
- N