PWD — Flow Cytometric Test System For Hematopoietic Neoplasms Class II
FDA product code PWD covers "Flow Cytometric Test System For Hematopoietic Neoplasms", a Class II medical device regulated under 21 CFR 864.7010. Submissions are reviewed by the Hematology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PWD
- Device Class
- Class II
- Regulation Number
- 864.7010
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
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)