510(k) DEN200062
- Device
- Parsortix PC1 Device
- Applicant
- Angle Europe , Ltd.
- 510(k) number
- DEN200062
- Product code
- QSA
- Decision
- Unknown (DENG)
- Decision date
- 2022-05-24
- Date received
- 2020-09-28
- Regulation
- 866.6110
- Classification name
- Circulating Tumor Cell (Ctc) Enrichment Device
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Andrew Newland
- Address
- 10 Nugent Rd. Guildford GB GU2 7AF GU2 7AF
FDA Registration Numbers#
- 3002806730
Source Documents#
510(k) summary PDF not indicated by FDA