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510(k) K810664

Device
ISOLATOR SYSTEM
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
510(k) number
K810664
Product code
JKA  
Decision
Substantially Equivalent (SESE)
Decision date
1981-03-31
Date received
1981-03-11
Regulation
862.1675
Classification name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Medical specialty
Clinical Chemistry
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JKA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.2026-06-02
K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company2026-04-15
K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and Company2026-04-10
K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and Company2026-04-10
K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company2026-03-13
K251812Steripath® Flow™ Blood Collection SystemMagnolia Medical Technologies2025-09-25
K243207BD Vacutainer® Eclipse™ Blood Collection NeedleBecton, Dickinson and Company2025-07-03
K250961Blood collection tube holdersPromisemed Hangzhou Meditech Co., Ltd.2025-06-04
K244047Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)Venocare, Inc.2025-05-23
K250907Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetSol-Millennium Medical, Inc.2025-04-30
K243649BD Vacutainer® Multiple Sample Luer AdapterBecton, Dickinson and Company2025-03-21
K241586PIVO™ Pro Needle-free Blood Collection DeviceBecton Dickinson Infusion Therapy Systems, Inc.2025-02-27
K242320BD Vacutainer® One Use HolderBecton, Dickinson and Company2024-11-01
K233979VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc.2024-07-19
K232781Safety Sliding Blood Collection SetJiangsu Caina Medical Co.,Ltd2024-03-07

Legacy Summary#

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FDA Review#

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