GKRClass II

System, Hemoglobin, Automated

21 CFR 864.5620 / Hematology

GKR is the FDA product code for System, Hemoglobin, Automated, a class II device type, regulated under 21 CFR 864.5620. As of 2026-09-10, FDA records hold 39 510(k) clearances under this code, the most recent dated 2020-08-04, and 8 recalls.

Classification record

Product code: GKR
Device name: System, Hemoglobin, Automated
Regulation: 21 CFR 864.5620
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: 39
Ingested recalls: 8

Clearances, product code GKR

By decision year

39 clearances under product code GKR with a decision year between 1977 and 2020, 2003 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code GKR by decision year
Year	Clearances
1977	1
1978	2
1979	1
1980	3
1981	1
1983	2
1984	1
1985	2
1987	2
1988	1
1991	1
1995	2
1996	1
2002	2
2003	4
2004	1
2006	1
2008	1
2009	1
2011	1
2013	2
2017	1
2018	2
2019	1
2020	2

Applicants with the most clearances

Product code GKR

Applicants holding the most 510(k) clearances under product code GKR
Applicant	Clearances
HemoCue AB	6
Ekf Diagnostic GmbH	4
Stanbio Laboratory	3
Helena Laboratories, Corp.	2
Hematology Marketing Assoc.	2
Immunostics, Inc.	2
Acon Laboratories, Inc.	1
Aktiebolaget Leo Diagnostics	1
Avl Scientific Corp.	1
Bayer Diagnostics Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order