JPKClass II

Mixture, Hematology Quality Control

21 CFR 864.8625 / Hematology

JPK is the FDA product code for Mixture, Hematology Quality Control, a class II device type, regulated under 21 CFR 864.8625. As of 2026-09-10, FDA records hold 192 510(k) clearances under this code, the most recent dated 2016-12-22, and 16 recalls.

Classification record

Product code: JPK
Device name: Mixture, Hematology Quality Control
Regulation: 21 CFR 864.8625
Device class: Class II
Review panel: Hematology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 192
Ingested recalls: 16

Clearances, product code JPK

By decision year

192 clearances under product code JPK with a decision year between 1976 and 2016, 1984 the highest year at 15.

Show the numbers

510(k) clearances under FDA product code JPK by decision year
Year	Clearances
1976	5
1977	5
1978	11
1979	14
1980	14
1981	5
1982	3
1983	4
1984	15
1985	11
1986	4
1987	2
1988	1
1989	4
1990	4
1991	4
1992	1
1993	2
1994	8
1995	4
1996	6
1997	4
1998	1
1999	4
2000	4
2001	9
2002	4
2003	1
2004	5
2005	3
2006	6
2007	5
2009	5
2010	4
2011	1
2012	2
2013	1
2014	2
2016	4

Applicants with the most clearances

Product code JPK

Applicants holding the most 510(k) clearances under product code JPK
Applicant	Clearances
R & D Systems, Inc.	45
Streck Laboratories, Inc.	23
Streck LLC	12
Siemens Healthcare Diagnostics Inc.	10
Coulter Electronics, Inc.	8
Bhp Diagnostix, Inc.	7
Hematronix, Inc.	6
American Dade	5
Coulter Corp.	5
Fisher Scientific Company L.L.C.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order