PWD
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Flow Cytometric Test System For Hematopoietic Neoplasms
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7010
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
- FDA definition
- Reagents intended for in vitro diagnostic use as a panel for qualitative identification of cell populations by multiparameter immunophenotyping on a flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin's lymphoma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN)
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| Record | Firm | Date |
|---|---|---|
| ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer (K183592) | Beckman Coulter | 2019-03-21 |
| ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M (DEN160047) | Beckman Coulter | 2017-06-29 |
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Every clearance here is in the API, with alerts when new ones post.