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Euroimmun Anti-M2-3E Elisa (Igg)

by Euroimmun Us, Inc. 510(k)

Active United States

510(k) K092736

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK092736 Date2 Sep 2010ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DBM
Device Class
Class II
Regulation
21 CFR Part 866.5090
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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