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Tdx(R)/Tdx(R)Flx(R)Mehtotrexate II

by Abbott Laboratories

510(k) K932615

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK932615 Date14 Jul 1993ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1056-2007 FDA Unclassified (pre-2012) initiated 20 Mar 2007

    Incorrect configuration: kits contain reagent bottles in the order S-W-T-P instead of the correct order, W-S-T-P.

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  • Withdrawn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
LAO
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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