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FDA 510(k)

Cytomics FC 500 Series (MPL or MCL) Flow Cytometer

K-Number: K182886 · 2019-09-06

ApplicantBeckman Coulter
Decision Date2019-09-06
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Cytomics FC 500 Series (MPL or MCL) Flow Cytometer is a medical device manufactured by Beckman Coulter. It received FDA 510(k) clearance on 2019-09-06 under approval number K182886. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cytomics FC 500 Series (MPL or MCL) Flow Cytometer?

Cytomics FC 500 Series (MPL or MCL) Flow Cytometer is a medical device that received FDA 510(k) clearance on 2019-09-06. It is manufactured by Beckman Coulter. The 510(k) number is K182886.

When was Cytomics FC 500 Series (MPL or MCL) Flow Cytometer approved by the FDA?

Cytomics FC 500 Series (MPL or MCL) Flow Cytometer received FDA 510(k) clearance on 2019-09-06, under approval number K182886.

What company makes Cytomics FC 500 Series (MPL or MCL) Flow Cytometer?

Cytomics FC 500 Series (MPL or MCL) Flow Cytometer is manufactured by Beckman Coulter.

What is the FDA product code for Cytomics FC 500 Series (MPL or MCL) Flow Cytometer?

The FDA product code for Cytomics FC 500 Series (MPL or MCL) Flow Cytometer is GKZ.

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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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