510(k) DEN160047
DEN160047 is an FDA 510(k) premarket notification submitted by Beckman Coulter for the device "ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M". The FDA issued a decision of De Novo Granted on June 29, 2017. 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
- DENG (De Novo Granted)
- Decision Date
- June 29, 2017
- Date Received
- October 3, 2016
- Clearance Type
- Direct
- 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)