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FDA 510(k)

Access anti-HBc Total

K-Number: K253687 · 2026-02-19

ApplicantBeckman Coulter, Inc.
Decision Date2026-02-19
Product CodeSEI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Access anti-HBc Total is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2026-02-19 under approval number K253687. 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 Total?

Access anti-HBc Total is a medical device that received FDA 510(k) clearance on 2026-02-19. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K253687.

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

Access anti-HBc Total received FDA 510(k) clearance on 2026-02-19, under approval number K253687.

What company makes Access anti-HBc Total?

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

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

The FDA product code for Access anti-HBc Total is 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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