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West Nile Virus Elisa Igg, Model EL0300G

by Focus Technologies, Inc.

510(k) K031953

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031953 Date22 Oct 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0182-2013 FDA Class III initiated 3 Oct 2012

    The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NOP
Device Class
Class II
Regulation
21 CFR Part 866.3940
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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