GKLClass II

Counter, Cell, Automated (Particle Counter)

21 CFR 864.5200 / Hematology

GKL is the FDA product code for Counter, Cell, Automated (Particle Counter), a class II device type, regulated under 21 CFR 864.5200. As of 2026-09-10, FDA records hold 130 510(k) clearances under this code, the most recent dated 2016-05-27, and 10 recalls.

Classification record

Product code: GKL
Device name: Counter, Cell, Automated (Particle Counter)
Regulation: 21 CFR 864.5200
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: Yes
Ingested clearances: 130
Ingested recalls: 10

Clearances, product code GKL

By decision year

130 clearances under product code GKL with a decision year between 1976 and 2016, 1984 the highest year at 13.

Show the numbers

510(k) clearances under FDA product code GKL by decision year
Year	Clearances
1976	3
1977	9
1978	7
1979	5
1980	8
1981	5
1982	4
1983	12
1984	13
1985	9
1986	13
1987	8
1988	4
1989	3
1991	5
1992	3
1993	1
1994	1
1995	1
1996	3
1997	2
1998	2
1999	1
2000	1
2002	1
2004	1
2005	2
2007	1
2010	1
2016	1

Applicants with the most clearances

Product code GKL

Applicants holding the most 510(k) clearances under product code GKL
Applicant	Clearances
Coulter Electronics, Inc.	17
Toa Medical Electronics USA, Inc.	15
BD Becton Dickinson Vacutainer Systems Preanalytic	11
Technicon Instruments Corp.	8
Abbott Diagnostics	7
Diagnostic Technology, Inc.	5
Instrumentation Laboratory Co.	4
Sysmex Corporation	4
Coulter Corp.	3
Hycel, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order