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FDA 510(k)

ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer

K-Number: K183592 · 2019-03-21

ApplicantBeckman Coulter
Decision Date2019-03-21
Product CodePWD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer is a medical device manufactured by Beckman Coulter. It received FDA 510(k) clearance on 2019-03-21 under approval number K183592. The device is classified under product code PWD. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer?

ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer is a medical device that received FDA 510(k) clearance on 2019-03-21. It is manufactured by Beckman Coulter. The 510(k) number is K183592.

When was ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer approved by the FDA?

ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer received FDA 510(k) clearance on 2019-03-21, under approval number K183592.

What company makes ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer?

ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer is manufactured by Beckman Coulter.

What is the FDA product code for ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer?

The FDA product code for ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer is PWD.

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Related Devices (Code: PWD)

DEN160047ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab MBeckman Coulter

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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