PWD · Class II · 21 CFR 864.7010

FDA Product Code PWD: Flow Cytometric Test System For Hematopoietic Neoplasms

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)

Leading manufacturers include Beckman Coulter.

2
Total
1
Cleared
180d
Avg days
2017
Since

FDA 510(k) Cleared Flow Cytometric Test System For Hematopoietic Neoplasms Devices (Product Code PWD)

2 devices
1–2 of 2
Cleared Mar 21, 2019
ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
K183592
Beckman Coulter
Immunology · 90d
Not Cleared Jun 29, 2017
ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M
DEN160047
Beckman Coulter
Immunology · 269d

About Product Code PWD - Regulatory Context