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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 the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2026-03-13 under 510(k) 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. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K254059.

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

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

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

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 IgM?

The FDA product code for Access anti-HBc IgM 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.

K252169Access BNP IIK253687Access anti-HBc TotalK251995Access anti-HAV IgMK250588Access Rubella IgGPMA P980041KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTSPMA P230015Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

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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 DiagnosticsK253687Access anti-HBc TotalBeckman 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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