Flow Cytometric Test System For Hematopoietic Neoplasms
The Flow Cytometric Test System For Hematopoietic Neoplasms is a hematology in vitro diagnostic device consisting of reagents intended for qualitative identification of cell populations by multiparameter immunophenotyping on a flow cytometer, used as an aid in the differential diagnosis of patients with or suspected of having hematopoietic neoplasms including chronic leukemia, acute leukemia, non-Hodgkin's lymphoma, myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms. It is classified as FDA Class II under regulation 21 CFR 864.7010, requiring 510(k) clearance and compliance with general and special controls, and is eligible for third-party review. The product code is PWD and it falls under the Hematology medical specialty. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PWD
- Device Class
- FDA class 2
- Regulation Number
- 864.7010
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
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)
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K183592 | ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer | Mar 21, 2019 | Substantially Equivalent | Beckman Coulter |
| DEN160047 | ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M | Jun 29, 2017 | Unknown | Beckman Coulter |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.