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510(k) BK210584

Device
Set, Transfer (Blood/Plasma)
Applicant
GenesisBPS, LLC
510(k) number
BK210584
Product code
KSB  
Decision
Substantially Equivalent (SE)
Decision date
2022-07-15
Date received
2021-04-22
Regulation
864.9875
Classification name
Set, Transfer (blood/plasma)
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Clearance type
510(k) Traditio
Third party reviewed
No

Other 510(k) Records For Product Code KSB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc.2018-09-28
K001043KAWASUMI LABORATORY BLOOD DRAWING KITKawasumi Laboratories America, Inc.2000-05-19
K820447ALPHA PLASMA TRANSFER SETAlpha Therapeutic Corp.1982-04-14
K802940SUPER-SPIKE TRANSFER SETGeneva Laboratories, Inc.1981-01-15
K791130FLU-VEN TK-2Venospital, Inc.1979-09-04
K791131FLU VEN TR-1Venospital, Inc.1979-09-04

Legacy Summary#

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FDA Review#

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