FDA.reportPublic FDA data

510(k) K213670

Device
BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
Applicant
Becton, Dickinson and Company
510(k) number
K213670
Product code
GIM
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-25
Date received
2021-11-22
Regulation
862.1675
Classification name
Tubes, Vacuum Sample, With Anticoagulant
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Katherine Kenner Lemus
Address
1 Becton Dr. Franklin Lakes NJ US 07417 07417

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GIM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240455BD Vacutainer® Citrate Blood Collection TubesBecton, Dickinson and Company2024-10-31
K230493BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection TubeBecton, Dickinson and Company2023-11-27
K162723TransFix/EDTA Vacuum Blood Collection TubesCaltag Medsystems, Ltd.2017-06-22
K080552CYTO-CHEX BCTStreck2008-07-31
K012152DS30 HCY BLOOD COLLECTION TUBESDrew Scientific , Ltd.2001-09-18
K971449VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)Becton Dickinson Vacutainer Systems1997-06-17
K971221GREINER VACUETTE BLOOD COLLECTION TUBEGreiner America, Inc.1997-05-02
K951886LOK-ON NEEDLE DISPOSAL SYSTEMBecton Dickinson Vacutainer Systems1995-06-30
K945458VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic1995-02-06
K944814CORVAC PLASTIC BLOOD COLLECTION TUBESherwood Medical Co.1994-12-19
K940058MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPERSherwood Medical Co.1994-05-02
K933939BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERTOrganon Teknika Corp.1994-02-07
K933386VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic1993-10-12
K922858MULTIDRAW SYSTEMCambridge Multi-Draw, Inc.1992-11-16
K922468ANGEL WING SETS -- MODIFIEDMbo Laboratories, Inc.1992-07-10