Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Elecsys Anti-HBc II

K-Number: K260046 · 2026-04-07

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

Device Summary

Elecsys Anti-HBc II 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 K260046. 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 II?

Elecsys Anti-HBc II 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 K260046.

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

Elecsys Anti-HBc II received FDA 510(k) clearance on 2026-04-07, under 510(k) number K260046.

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

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 II?

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

Other records listing Roche Diagnostics 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.

K252323cobas pulse blood glucose monitoring systemPMA P990056Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancerPMA P000027PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERSK252431Elecsys CalcitoninK252280Elecsys Anti-SARS-CoV-2 SK260049Elecsys Anti-HBc IgM

View all 84 devices →

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 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.

↑