JISClass II

Calibrator, Primary

21 CFR 862.1150 / Clinical Chemistry

JIS is the FDA product code for Calibrator, Primary, a class II device type, regulated under 21 CFR 862.1150. As of 2026-09-10, FDA records hold 130 510(k) clearances under this code, the most recent dated 2012-08-14, and 21 recalls.

Classification record

Product code: JIS
Device name: Calibrator, Primary
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: 130
Ingested recalls: 21

Clearances, product code JIS

By decision year

130 clearances under product code JIS with a decision year between 1976 and 2012, 1982 the highest year at 13.

Show the numbers

510(k) clearances under FDA product code JIS by decision year
Year	Clearances
1976	1
1977	2
1978	2
1979	2
1980	8
1981	12
1982	13
1983	3
1984	9
1985	1
1986	7
1987	6
1988	3
1989	2
1990	1
1991	3
1992	6
1993	7
1994	3
1995	4
1996	2
1997	1
1998	1
1999	2
2000	11
2001	6
2002	2
2003	6
2005	1
2006	2
2012	1

Applicants with the most clearances

Product code JIS

Applicants holding the most 510(k) clearances under product code JIS
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	12
E.I. Dupont de Nemours & Co., Inc.	8
FUJIFILM Healthcare Americas Corporation	7
Boehringer Mannheim Corp.	5
Gilford Diagnostics	5
Roche Diagnostics GmbH	5
Syva Co.	5
EMD Millipore Corporation	4
In Vitro Diagnostics, Inc.	4
Windsor Laboratories, Inc.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 61 companies shown, in name order