FDA 510(k)

Access EPO

K-Number: K240182 · 2024-04-22

Decision Date2024-04-22

Product CodeGGT

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

Access EPO is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-04-22 under 510(k) number K240182. The device is classified under product code GGT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access EPO?

Access EPO is a medical device that received FDA 510(k) clearance on 2024-04-22. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K240182.

When did Access EPO receive FDA 510(k) clearance?

Access EPO received FDA 510(k) clearance on 2024-04-22, under 510(k) number K240182.

Who is the listed applicant for Access EPO?

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

What is the FDA product code for Access EPO?

The FDA product code for Access EPO is GGT.

Other records listing Beckman Coulter, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.