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FDA 510(k), K183592, ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
FDA 510(k), K183592, ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
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510(K) Number: K183592
Device Name: ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
Manufacturer: Beckman Coulter
Device Classification Name: flow cytometric test system for hematopoietic neoplasms
Regulation Number: 864.7010
Classification Product Code: PWD
Date Received: 12/21/2018
Decision Date: 03/21/2019
Regulation Medical Specialty: Hematology
Device Name: ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
Manufacturer: Beckman Coulter
Device Classification Name: flow cytometric test system for hematopoietic neoplasms
Regulation Number: 864.7010
Classification Product Code: PWD
Date Received: 12/21/2018
Decision Date: 03/21/2019
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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