JJEClass I

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

21 CFR 862.2160 / Clinical Chemistry

JJE is the FDA product code for Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a class I device type, regulated under 21 CFR 862.2160. As of 2026-09-10, FDA records hold 208 510(k) clearances under this code, the most recent dated 2019-02-12, and 561 recalls.

Classification record

Product code: JJE
Device name: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Regulation: 21 CFR 862.2160
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: 208
Ingested recalls: 561

Clearances, product code JJE

By decision year

208 clearances under product code JJE with a decision year between 1976 and 2019, 1984 the highest year at 19.

Show the numbers

510(k) clearances under FDA product code JJE by decision year
Year	Clearances
1976	1
1977	3
1978	7
1979	5
1980	7
1981	9
1982	5
1983	14
1984	19
1985	10
1986	11
1987	13
1988	16
1989	14
1990	7
1991	3
1992	10
1993	7
1994	6
1995	11
1996	6
1997	4
1998	3
2000	2
2001	1
2003	1
2005	3
2006	1
2008	1
2011	2
2012	1
2013	1
2014	3
2019	1

Applicants with the most clearances

Product code JJE

Applicants holding the most 510(k) clearances under product code JJE
Applicant	Clearances
Eastman Kodak Company	18
Boehringer Mannheim Corp.	16
Abbott Medical	13
Beckman Instruments, Inc.	9
Ciba Corning Diagnostics Corp.	7
E.I. Dupont de Nemours & Co., Inc.	7
Gilford Instrument Laboratories, Inc.	7
American Monitor Corp.	5
Siemens Healthcare Diagnostics Inc.	5
Olympus Corp.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 148 companies shown, in name order