JJXClass I

Single (Specified) Analyte Controls (Assayed And Unassayed)

21 CFR 862.1660 / Clinical Chemistry

JJX is the FDA product code for Single (Specified) Analyte Controls (Assayed And Unassayed), a class I device type, regulated under 21 CFR 862.1660. As of 2026-09-10, FDA records hold 493 510(k) clearances under this code, the most recent dated 2017-04-04, and 42 recalls.

Classification record

Product code: JJX
Device name: Single (Specified) Analyte Controls (Assayed And Unassayed)
Regulation: 21 CFR 862.1660
Device class: Class I
Review panel: Clinical Chemistry
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 493
Ingested recalls: 42

Clearances, product code JJX

By decision year

493 clearances under product code JJX with a decision year between 1976 and 2017, 1996 the highest year at 30.

Show the numbers

510(k) clearances under FDA product code JJX by decision year
Year	Clearances
1976	2
1977	3
1978	1
1979	8
1980	6
1981	4
1982	7
1983	7
1984	3
1985	4
1986	5
1987	4
1988	4
1989	9
1990	8
1991	10
1992	19
1993	25
1994	17
1995	14
1996	30
1997	23
1998	23
1999	15
2000	19
2001	13
2002	11
2003	9
2004	21
2005	9
2006	11
2007	6
2008	8
2009	17
2010	24
2011	19
2012	15
2013	19
2014	22
2015	11
2016	6
2017	2

Applicants with the most clearances

Product code JJX

Applicants holding the most 510(k) clearances under product code JJX
Applicant	Clearances
Roche Diagnostics GmbH	60
Siemens Healthcare Diagnostics Inc.	55
Boehringer Mannheim Corp.	24
Bionostics, Inc.	22
Bio-Rad	21
Ortho-Clinical Diagnostics, Inc.	18
Casco Standards	10
Tosoh Medics, Inc.	10
Aalto Scientific Ltd.	9
Streck Laboratories, Inc.	9

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 232 companies shown, in name order