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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 the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2026-02-19 under 510(k) 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. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K253687.

When did Access anti-HBc Total receive FDA 510(k) clearance?

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

Who is the listed applicant for Access anti-HBc Total?

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 anti-HBc Total?

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

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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Related Devices (Code: SEI)

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.

K260049Elecsys Anti-HBc IgMRoche DiagnosticsK260046Elecsys Anti-HBc IIRoche DiagnosticsK254059Access anti-HBc IgMBeckman Coulter, Inc.

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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