JHXClass II

Fluorometric Method, Cpk Or Isoenzymes

21 CFR 862.1215 / Clinical Chemistry

JHX is the FDA product code for Fluorometric Method, Cpk Or Isoenzymes, a class II device type, regulated under 21 CFR 862.1215. As of 2026-09-10, FDA records hold 48 510(k) clearances under this code, the most recent dated 2024-02-16, and 15 recalls.

Classification record

Product code: JHX
Device name: Fluorometric Method, Cpk Or Isoenzymes
Regulation: 21 CFR 862.1215
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: 48
Ingested recalls: 15

Clearances, product code JHX

By decision year

48 clearances under product code JHX with a decision year between 1976 and 2024, 1980 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code JHX by decision year
Year	Clearances
1976	1
1977	2
1979	2
1980	4
1981	3
1982	1
1984	1
1987	4
1988	2
1989	1
1990	1
1991	2
1992	1
1996	1
1997	2
1998	2
1999	3
2000	2
2001	2
2002	1
2003	1
2004	3
2005	1
2009	1
2012	1
2017	1
2022	1
2024	1

Applicants with the most clearances

Product code JHX

Applicants holding the most 510(k) clearances under product code JHX
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	11
Intl. Immunoassay Laboratories, Inc.	5
Corning Medical & Scientific	4
Helena Laboratories, Corp.	3
Ciba Corning Diagnostics Corp.	2
Ortho-Clinical Diagnostics, Inc.	2
Radiometer Medical ApS	2
Ac Biochemicals, Inc.	1
American Dade	1
Beckman Instruments, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order