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 a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2026-04-07 under approval 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. It is manufactured by Roche Diagnostics. The 510(k) number is K260049.
When was Elecsys Anti-HBc IgM approved by the FDA?
Elecsys Anti-HBc IgM received FDA 510(k) clearance on 2026-04-07, under approval number K260049.
What company makes Elecsys Anti-HBc IgM?
Elecsys Anti-HBc IgM is manufactured by Roche Diagnostics.
What is the FDA product code for Elecsys Anti-HBc IgM?
The FDA product code for Elecsys Anti-HBc IgM 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.