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FDA 510(k)

Access anti-HBc IgM

K-Number: K254059 · 2026-03-13

ApplicantBeckman Coulter, Inc.
Decision Date2026-03-13
Product CodeSEI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Access anti-HBc IgM is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2026-03-13 under approval number K254059. The device is classified under product code SEI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access anti-HBc IgM?

Access anti-HBc IgM is a medical device that received FDA 510(k) clearance on 2026-03-13. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K254059.

When was Access anti-HBc IgM approved by the FDA?

Access anti-HBc IgM received FDA 510(k) clearance on 2026-03-13, under approval number K254059.

What company makes Access anti-HBc IgM?

Access anti-HBc IgM is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access anti-HBc IgM?

The FDA product code for Access anti-HBc IgM is SEI.

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Related Devices (Code: SEI)

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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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