JITClass II

Calibrator, Secondary

21 CFR 862.1150 / Clinical Chemistry

JIT is the FDA product code for Calibrator, Secondary, a class II device type, regulated under 21 CFR 862.1150. As of 2026-09-10, FDA records hold 245 510(k) clearances under this code, the most recent dated 2017-05-16, and 55 recalls.

Classification record

Product code: JIT
Device name: Calibrator, Secondary
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: 245
Ingested recalls: 55

Clearances, product code JIT

By decision year

245 clearances under product code JIT with a decision year between 1976 and 2017, 1987 the highest year at 16.

Show the numbers

510(k) clearances under FDA product code JIT by decision year
Year	Clearances
1976	2
1977	12
1978	7
1979	2
1980	3
1982	13
1983	3
1984	10
1985	6
1986	2
1987	16
1988	4
1989	3
1990	3
1991	3
1994	3
1995	1
1996	3
1997	5
1998	10
1999	6
2000	4
2001	13
2002	10
2003	6
2004	15
2005	7
2006	15
2007	5
2008	6
2009	2
2010	6
2011	7
2012	2
2013	5
2014	10
2015	4
2016	4
2017	7

Applicants with the most clearances

Product code JIT

Applicants holding the most 510(k) clearances under product code JIT
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	48
Roche Diagnostics GmbH	18
FUJIFILM Healthcare Americas Corporation	15
E.I. Dupont de Nemours & Co., Inc.	10
DIAMOND DIAGNOSTICS Inc	9
Kmn Products, Inc.	7
Abbott Medical	6
Fujirebio Diagnostics, Inc.	5
Reference Diagnostics, Inc.	5
Tosoh Bioscience Inc	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 105 companies shown, in name order