FDA 510(k)

Access Ferritin

K-Number: K234052 · 2024-03-20

Decision Date2024-03-20

Product CodeJMG

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

Access Ferritin 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 2024-03-20 under 510(k) number K234052. The device is classified under product code JMG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access Ferritin?

Access Ferritin is a medical device that received FDA 510(k) clearance on 2024-03-20. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K234052.

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

Access Ferritin received FDA 510(k) clearance on 2024-03-20, under 510(k) number K234052.

Who is the listed applicant for Access Ferritin?

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 Ferritin?

The FDA product code for Access Ferritin is JMG.

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

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