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Esensor Cf Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument, Models Xt-8

by Osmetech Molecular Diagnostics

510(k) K090901

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK090901 Date6 Jul 2009ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2208-2020 FDA Class II initiated 14 Jun 2019 on shared 510(k) K090901
    • Terminated Z-2209-2020 FDA Class II initiated 14 Jun 2019 on shared 510(k) K090901

    Incorrect Peel-Apart Introducer Sheath in Kit.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
NUA
Device Class
Class II
Regulation
21 CFR Part 866.5900
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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