Product code PWD— Hematology
BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5)
- Classification name
- Flow Cytometric Test System For Hematopoietic Neoplasms
- Device class
- Class 2
- Regulation
- 21 CFR 864.7010
- Advisory panel
- Hematology
- Total cleared
- 3
- First cleared
- Most recent
FDA classification 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)”
Market context for product code PWD
FDA has cleared devices under product code PWD between 2017 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2019
- 2017
Top applicants under product code PWD
Recent clearances under product code PWD
- K260215 — BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5)
- K183592 — ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
- DEN160047 — ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M
Data sourced from openFDA. This site is unofficial and independent of the FDA.