Tray, Blood Collection

FDA product code GJE · Class II (moderate risk) · 21 CFR 862.1675 · Clinical Chemistry

7510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K962596Customed Blood Extraction KitGJE · Traditional Customed, Inc.09/27/1996SE
K925468JJ Skinner Carekits(Tm) Blood Collection KitGJE · Traditional J.J. Skinner, Inc.04/11/1994SEKD
K780303Auto Iso-Filter Collection Tube CapGJE · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic03/30/1978SE
K771489Rterial Blood Sampling KitGJE · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic08/22/1977SE
K771370Icrotaineo Brand TubeGJE · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic08/03/1977SE
K761177Sodium CitrateGJE · Traditional Bio/Data Corp.01/10/1977SE
K760086Tray, Blood Sampling (Pulsator II)GJE · Traditional Concord Laboratories, Inc.07/16/1976SE

Recalls

RecallProductFirmInitiated
Z-0313-2024 Class II24 BLOOD CULTURE KIT, REF DYNDH1632This recall is being issued due to items within the kit have expired prior to the overall kit expiration… MEDLINE INDUSTRIES, LP - Northfield11/01/2023Open, Classified