JHWClass II

U.V. Method, Cpk Isoenzymes

21 CFR 862.1215 / Clinical Chemistry

JHW is the FDA product code for U.V. Method, Cpk Isoenzymes, a class II device type, regulated under 21 CFR 862.1215. As of 2026-09-10, FDA records hold 27 510(k) clearances under this code, the most recent dated 2017-05-26, and 2 recalls.

Classification record

Product code: JHW
Device name: U.V. Method, Cpk 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: 27
Ingested recalls: 2

Clearances, product code JHW

By decision year

27 clearances under product code JHW with a decision year between 1977 and 2017, 1981 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code JHW by decision year
Year	Clearances
1977	1
1978	1
1979	1
1980	1
1981	5
1982	1
1988	2
1990	1
1991	3
1993	1
1994	2
1995	2
1996	1
2000	1
2003	1
2012	1
2014	1
2017	1

Applicants with the most clearances

Product code JHW

Applicants holding the most 510(k) clearances under product code JHW
Applicant	Clearances
Intl. Immunoassay Laboratories, Inc.	5
Harleco	3
Abbott Medical	2
Biochemical Trade, Inc.	2
ELITechGroup Inc	2
Roche Diagnostics GmbH	2
Boehringer Mannheim Corp.	1
Diagnostic Systems Laboratories, Inc.	1
Electrophoresis Corp. of America	1
Helena Laboratories, Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code