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Euroimmun Anti-PLA2R Elisa (Igg)

by Euroimmun Us, Inc. 510(k)

Active United States

510(k) K132195

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK132195 Date27 Jun 2014ClearedStatusActive

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  • Withdrawn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 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
PGV
Device Class
Class II
Regulation
21 CFR Part 866.5780
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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