510(k) DEN200062
DEN200062 is an FDA 510(k) premarket notification submitted by Angle Europe , Ltd. for the device "Parsortix PC1 Device". The FDA issued a decision of De Novo Granted on May 24, 2022. The device falls under product code QSA (Circulating Tumor Cell (Ctc) Enrichment Device), a Class II device regulated under 21 CFR 866.6110.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 24, 2022
- Date Received
- September 28, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Circulating Tumor Cell (Ctc) Enrichment Device
- Device Class
- Class II
- Regulation Number
- 866.6110
- Review Panel
- PA
- Submission Type
A circulating tumor cell enrichment device is an in vitro diagnostic device used to enrich circulating tumor cells from the peripheral blood of patients diagnosed with cancer for subsequent in vitro diagnostic testing.