JFYClass II

Enzymatic Method, Creatinine

21 CFR 862.1225 / Clinical Chemistry

JFY is the FDA product code for Enzymatic Method, Creatinine, a class II device type, regulated under 21 CFR 862.1225. As of 2026-09-10, FDA records hold 49 510(k) clearances under this code, the most recent dated 2026-02-20, and 29 recalls.

Classification record

Product code: JFY
Device name: Enzymatic Method, Creatinine
Regulation: 21 CFR 862.1225
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: 49
Ingested recalls: 29

Clearances, product code JFY

By decision year

49 clearances under product code JFY with a decision year between 1981 and 2026, 2007 the highest year at 8.

Show the numbers

510(k) clearances under FDA product code JFY by decision year
Year	Clearances
1981	1
1984	1
1986	2
1987	1
1988	1
1990	1
1991	2
1998	1
1999	1
2000	2
2001	2
2002	2
2003	1
2005	1
2006	2
2007	8
2008	4
2009	3
2011	2
2014	2
2016	1
2017	1
2018	2
2019	2
2021	2
2026	1

Applicants with the most clearances

Product code JFY

Applicants holding the most 510(k) clearances under product code JFY
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	6
Ortho-Clinical Diagnostics, Inc.	5
Boehringer Mannheim Corp.	4
Horiba Abx SAS	2
Roche Diagnostics GmbH	2
Teco Diagnostics	2
Acon Laboratories, Inc.	1
Alfa Wassermann	1
Axis-Shield Poc AS	1
Bayer Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 42 companies shown, in name order