JIXClass II

Calibrator, Multi-Analyte Mixture

21 CFR 862.1150 / Clinical Chemistry

JIX is the FDA product code for Calibrator, Multi-Analyte Mixture, a class II device type, regulated under 21 CFR 862.1150. As of 2026-09-10, FDA records hold 302 510(k) clearances under this code, the most recent dated 2016-05-20, and 73 recalls.

Classification record

Product code: JIX
Device name: Calibrator, Multi-Analyte Mixture
Regulation: 21 CFR 862.1150
Device class: Class II
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: 302
Ingested recalls: 73

Clearances, product code JIX

By decision year

302 clearances under product code JIX with a decision year between 1976 and 2016, 1982 the highest year at 15.

Show the numbers

510(k) clearances under FDA product code JIX by decision year
Year	Clearances
1976	1
1977	5
1978	4
1979	11
1980	10
1981	5
1982	15
1983	5
1984	10
1985	10
1986	9
1987	11
1988	12
1989	2
1990	8
1991	3
1992	4
1993	10
1994	15
1995	7
1996	12
1997	9
1998	9
1999	9
2000	3
2001	10
2002	7
2003	15
2004	13
2005	5
2006	15
2007	6
2008	5
2009	4
2010	5
2011	7
2012	2
2013	4
2014	1
2015	3
2016	1

Applicants with the most clearances

Product code JIX

Applicants holding the most 510(k) clearances under product code JIX
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	34
Alko Diagnostic Corp.	21
Roche Diagnostics GmbH	14
Bhp Diagnostix, Inc.	11
Roche Diagnostic Systems, Inc.	9
Beckman Instruments, Inc.	8
Boehringer Mannheim Corp.	8
Gilford Diagnostics	7
Shaban Mfg. Co.	7
Medrad, Inc.	6

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 76 companies shown, in name order