ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
FDA 510(k) K183592 · Beckman Coulter
Submission
- Device name
- ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
- Applicant
- Beckman Coulter
Miami, FL, US - Received
- December 21, 2018
- Decision date
- March 21, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PWD – Flow Cytometric Test System For Hematopoietic Neoplasms
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7010
- Specialty
- Hematology
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…
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Questions and answers
When was ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer cleared by the FDA?
ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer (K183592) received a 510(k) decision of Substantially Equivalent on March 21, 2019, 90 days after the submission was received.
What is the product code of K183592?
The FDA product code is PWD – Flow Cytometric Test System For Hematopoietic Neoplasms, a Class II (moderate risk) device regulated under 21 CFR 864.7010.