GKT · Class II · 21 CFR 864.9245

FDA Product Code GKT: Separator, Automated, Blood Cell, Diagnostic

Leading manufacturers include Travenol Laboratories, S.A., Fresenius Kabi USA,Llc and Fresenius Kabi AG.

10
Total
10
Cleared
96d
Avg days
1977
Since

FDA 510(k) Cleared Separator, Automated, Blood Cell, Diagnostic Devices (Product Code GKT)

10 devices
1–10 of 10
Cleared Sep 11, 2020
AMICUS Separator System
K200530
Fresenius Kabi AG
Gastroenterology & Urology · 193d
Cleared Nov 23, 2016
AMICUS Separator System, AMICUS Separator System
K162462
Fresenius Kabi USA,Llc
Hematology · 82d
Cleared Oct 31, 1980
CELLTRIFUGE II
K801233
Travenol Laboratories, S.A.
Hematology · 157d
Cleared Aug 10, 1979
STERILE, DISPOSABLE CENTRIFUGE BOWL
K791106
Travenol Laboratories, S.A.
Hematology · 58d
Cleared May 24, 1979
TERUMO IMUGARD
K790105
Terumo America, Inc.
Hematology · 128d

About Product Code GKT - Regulatory Context