Parsortix PC1 Device
FDA 510(k) clearance DEN200062 · decided 2022-05-24
Clearance details
- K-number
- DEN200062
- Device name
- Parsortix PC1 Device
- Applicant
- Angle Europe , Ltd.
- Decision
- Unknown
- Date received
- 2020-09-28
- Decision date
- 2022-05-24
- Days to decision
- 603 days
- Clearance type
- Direct
- Product code
- QSA
- Device class
- 2
- Regulation number
- 866.6110
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Guildford, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.