Skip to content

Bd Max Mrsa Xt, Bd Max Instrument

by Geneohm Sciences Canada Inc

510(k) K133605

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 NumberK133605 Date20 Dec 2013ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2334-2019 FDA Class II initiated 17 Jul 2019

    The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

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  • Withdrawn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
NQX
FDA applicant
Geneohm Sciences Canada, Inc.
Device Class
Class II
Regulation
21 CFR Part 866.1640
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Other devices from Geneohm Sciences Canada Inc