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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 the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter. It received FDA 510(k) clearance on 2019-09-06 under 510(k) 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. The listed applicant is Beckman Coulter. The 510(k) number is K182886.

When did Cytomics FC 500 Series (MPL or MCL) Flow Cytometer receive FDA 510(k) clearance?

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

Who is the listed applicant for Cytomics FC 500 Series (MPL or MCL) Flow Cytometer?

The FDA 510(k) record lists Beckman Coulter as the applicant. This does not by itself establish the device manufacturer.

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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