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Greiner Vacuette Blood Collection Tube

by Greiner America, Inc. 4 variants

510(k) K971236

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK971236 Date12 May 1997ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2485-2021 FDA Class II initiated 13 Aug 2021

    Blood collection tubes may experience a clotting issue.

    • Terminated Z-0184-2012 FDA Unclassified (pre-2012) initiated 12 Aug 2011

    Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills.

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  • Withdrawn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
JKA
Device Class
Class II
Regulation
21 CFR Part 862.1675
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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