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Leucoprep(R) Brand Cell Separat Tube W/Sodium Citr

by Bd Becton Dickinson Vacutainer Systems Preanalytic

510(k) K911731

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 NumberK911731 Date15 Dec 1992ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2542-2014 FDA Class II initiated 3 Jul 2014

    BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells.

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  • Withdrawn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
JCF
Device Class
Class I
Regulation
21 CFR Part 864.8500
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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