FDA product code PWD: Flow Cytometric Test System For Hematopoietic Neoplasms
PWD is the FDA product code for flow cytometric test system for hematopoietic neoplasms. It is a Class II device, regulated under 21 CFR 864.7010 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under PWD. The average 510(k) review took 90 days (median 90). 1 De Novo request was granted under it.
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)
Classification
| Field | Value |
|---|---|
| Device name | Flow Cytometric Test System For Hematopoietic Neoplasms |
| Device class | Class II |
| Regulation | 21 CFR 864.7010 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PWD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 90 |
Compare with all 510(k) review times · Search every PWD clearance
Top PWD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Coulter | 1 | 2019-03-21 |
Most recent PWD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K183592 | Beckman Coulter | ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer | 2019-03-21 | 90 |
Recalls for PWD devices
openFDA lists no recalls for product code PWD.
Frequently asked questions
What is FDA product code PWD?
PWD is the FDA product code for flow cytometric test system for hematopoietic neoplasms. It is a Class II device, regulated under 21 CFR 864.7010 and reviewed by the Hematology panel.
What device class is PWD?
Class II, regulation 21 CFR 864.7010. Typical premarket route: 510(k).
How long does a 510(k) take for product code PWD?
Across 1 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most PWD clearances?
Beckman Coulter (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PWD
- Run a recall and safety report across every PWD manufacturer
- Watch product code PWD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Hematology product codes · FDA product code lookup · 510(k) database search · 510(k) review times