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FDA 510(k)

Elecsys Anti-HBc IgM

K-Number: K260049 · 2026-04-07

ApplicantRoche Diagnostics
Decision Date2026-04-07
Product CodeSEI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Elecsys Anti-HBc IgM is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2026-04-07 under 510(k) number K260049. 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 Elecsys Anti-HBc IgM?

Elecsys Anti-HBc IgM is a medical device that received FDA 510(k) clearance on 2026-04-07. The listed applicant is Roche Diagnostics. The 510(k) number is K260049.

When did Elecsys Anti-HBc IgM receive FDA 510(k) clearance?

Elecsys Anti-HBc IgM received FDA 510(k) clearance on 2026-04-07, under 510(k) number K260049.

Who is the listed applicant for Elecsys Anti-HBc IgM?

The FDA 510(k) record lists Roche Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elecsys Anti-HBc IgM?

The FDA product code for Elecsys Anti-HBc IgM is SEI.

Other records listing Roche Diagnostics as applicant

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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.

K260046Elecsys Anti-HBc IIRoche DiagnosticsK254059Access anti-HBc IgMBeckman Coulter, Inc.K253687Access 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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