510(k) K183592
K183592 is an FDA 510(k) premarket notification submitted by Beckman Coulter for the device "ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer". The FDA issued a decision of Substantially Equivalent on March 21, 2019. The device falls under product code PWD (Flow Cytometric Test System For Hematopoietic Neoplasms), a Class II device regulated under 21 CFR 864.7010. Beckman Coulter has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 2019
- Date Received
- December 21, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flow Cytometric Test System For Hematopoietic Neoplasms
- Device Class
- Class II
- Regulation Number
- 864.7010
- Review Panel
- HE
- Submission Type
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)