JFJClass II

Catalytic Methods, Amylase

21 CFR 862.1070 / Clinical Chemistry

JFJ is the FDA product code for Catalytic Methods, Amylase, a class II device type, regulated under 21 CFR 862.1070. As of 2026-09-10, FDA records hold 99 510(k) clearances under this code, the most recent dated 2022-05-26, and 2 recalls.

Classification record

Product code: JFJ
Device name: Catalytic Methods, Amylase
Regulation: 21 CFR 862.1070
Device class: Class II
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: 99
Ingested recalls: 2

Clearances, product code JFJ

By decision year

99 clearances under product code JFJ with a decision year between 1977 and 2022, 1986 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code JFJ by decision year
Year	Clearances
1977	5
1980	3
1982	3
1983	3
1985	2
1986	10
1987	7
1988	2
1989	4
1990	6
1991	4
1992	7
1993	5
1994	8
1995	2
1997	5
1998	2
1999	2
2000	1
2001	3
2002	3
2004	2
2006	2
2007	1
2008	1
2009	1
2012	1
2013	1
2019	2
2022	1

Applicants with the most clearances

Product code JFJ

Applicants holding the most 510(k) clearances under product code JFJ
Applicant	Clearances
Em Diagnostic Systems, Inc.	7
Abbott Medical	6
Genzyme Corporation	4
Horiba Instruments Incorporated	4
Siemens Healthcare Diagnostics Inc.	3
Boehringer Mannheim Corp.	3
Data Medical Associates, Inc.	3
Harleco	3
Instrumentation Laboratory Co.	3
Sclavo, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order