JIFClass I

Enzymatic Method, Ammonia

21 CFR 862.1065 / Clinical Chemistry

JIF is the FDA product code for Enzymatic Method, Ammonia, a class I device type, regulated under 21 CFR 862.1065. As of 2026-09-10, FDA records hold 30 510(k) clearances under this code, the most recent dated 2019-02-08, and 11 recalls.

Classification record

Product code: JIF
Device name: Enzymatic Method, Ammonia
Regulation: 21 CFR 862.1065
Device class: Class I
Review panel: Clinical Chemistry
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 30
Ingested recalls: 11

Clearances, product code JIF

By decision year

30 clearances under product code JIF with a decision year between 1976 and 2019, 1987 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code JIF by decision year
Year	Clearances
1976	1
1977	2
1982	1
1984	1
1987	4
1988	1
1991	1
1992	1
1994	2
1996	1
1998	3
1999	1
2000	2
2002	2
2003	1
2004	1
2005	1
2006	1
2013	2
2019	1

Applicants with the most clearances

Product code JIF

Applicants holding the most 510(k) clearances under product code JIF
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	5
Abbott Medical	3
Bayer Diagnostics Corp.	2
Sekisui Diagnostics P.E.I. Inc.	2
Em Diagnostic Systems, Inc.	2
American Dade	1
Baxter Healthcare Corporation	1
Beckman Instruments, Inc.	1
Boehringer Mannheim Corp.	1
Dade Intl., Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order