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Herpeselect 2 Elisa Igg, Model ELO920G

by Focus Technologies, Inc. 510(k)

Active United States

510(k) K021486

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK021486 Date1 Aug 2002ClearedStatusActive

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  • Withdrawn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
MXJ
Device Class
Class II
Regulation
21 CFR Part 866.3305
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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