LKN

FDA Product Code LKN: Separator, Automated, Blood Cell And Plasma, Therapeutic

Leading manufacturers include Terumobct, Inc., Fresenius Kabi USA,Llc and Fresenius Kabi AG.

27
Total
27
Cleared
152d
Avg days
1983
Since

FDA 510(k) Cleared Separator, Automated, Blood Cell And Plasma, Therapeutic Devices (Product Code LKN)

27 devices
1–24 of 27
Cleared Nov 13, 2019
AMICUS Separator System
K192150
Fresenius Kabi AG
Gastroenterology & Urology · 96d
Cleared Feb 05, 2019
Spectra Optia Apheresis System
K183081
Terumobct, Inc.
Gastroenterology & Urology · 91d
Cleared Dec 04, 2018
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
K180615
Fresenius Kabi USA,Llc
Gastroenterology & Urology · 271d
Cleared Nov 01, 2018
Spectra Optia Apheresis System
K181049
Terumobct, Inc.
Gastroenterology & Urology · 195d
Cleared Mar 02, 2018
Spectra Optia Apheresis System
K172590
Terumobct, Inc.
Gastroenterology & Urology · 185d
Cleared Jan 27, 1988
FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS
K874607
Organon Teknika Corp.
Gastroenterology & Urology · 79d

About Product Code LKN - Regulatory Context