DeviceClearance

Product code PWD— Hematology

ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer

Classification name
Flow Cytometric Test System For Hematopoietic Neoplasms
Device class
Class 2
Regulation
21 CFR 864.7010
Advisory panel
Hematology
Total cleared
2
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)”

— U.S. Food and Drug Administration, device classification record for product code PWD under 21 CFR 864.7010, via openFDA

Market context for product code PWD

FDA has cleared 2 devices under product code PWD between 2017 and 2019, filed by 1 applicant company. 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

Top applicants under product code PWD

Recent clearances under product code PWD

Data sourced from openFDA. This site is unofficial and independent of the FDA.