QSA
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Circulating Tumor Cell (Ctc) Enrichment Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6110
- Medical specialty
- Immunology
- FDA definition
- 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.
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| Record | Firm | Date |
|---|---|---|
| Parsortix PC1 Device (DEN200062) | Angle Europe , Ltd. | 2022-05-24 |
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Every clearance here is in the API, with alerts when new ones post.