GKTClass II

Separator, Automated, Blood Cell, Diagnostic

21 CFR 864.9245 / Hematology

GKT is the FDA product code for Separator, Automated, Blood Cell, Diagnostic, a class II device type, regulated under 21 CFR 864.9245. As of 2026-09-10, FDA records hold 10 510(k) clearances under this code, the most recent dated 2020-09-11, and one recall.

Classification record

Product code: GKT
Device name: Separator, Automated, Blood Cell, Diagnostic
Regulation: 21 CFR 864.9245
Device class: Class II
Review panel: Hematology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 10
Ingested recalls: 1

Clearances, product code GKT

By decision year

10 clearances under product code GKT with a decision year between 1977 and 2020, 1979 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code GKT by decision year
Year	Clearances
1977	2
1979	3
1980	1
1982	2
2016	1
2020	1

Applicants with the most clearances

Product code GKT

Applicants holding the most 510(k) clearances under product code GKT
Applicant	Clearances
Intl. Business Machines	2
Travenol Laboratories, S.A.	2
Cryosan, Inc.	1
Fresenius Kabi AB	1
Fresenius Kabi USA, LLC	1
Metrix Teknika, Inc.	1
Pheragen Technology Corp.	1
Terumo America, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order