DHAClass II

System, Test, Human Chorionic Gonadotropin

21 CFR 862.1155 / Clinical Chemistry

DHA is the FDA product code for System, Test, Human Chorionic Gonadotropin, a class II device type, regulated under 21 CFR 862.1155. As of 2026-09-10, FDA records hold 72 510(k) clearances under this code, the most recent dated 2024-05-08, and 14 recalls.

Classification record

Product code: DHA
Device name: System, Test, Human Chorionic Gonadotropin
Regulation: 21 CFR 862.1155
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: 72
Ingested recalls: 14

Clearances, product code DHA

By decision year

72 clearances under product code DHA with a decision year between 1986 and 2024, 1988 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code DHA by decision year
Year	Clearances
1986	1
1987	1
1988	9
1989	6
1991	2
1992	1
1993	1
1994	2
1995	3
1996	4
1997	4
1998	3
1999	3
2000	4
2001	2
2002	3
2003	2
2004	1
2006	1
2007	2
2008	1
2009	1
2013	2
2015	1
2017	2
2019	1
2020	1
2021	3
2022	1
2023	3
2024	1

Applicants with the most clearances

Product code DHA

Applicants holding the most 510(k) clearances under product code DHA
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	10
Abbott Medical	6
Germaine Laboratories, Inc.	4
Roche Diagnostics GmbH	3
Azog, Inc.	2
Baxter Healthcare Corporation	2
Boehringer Mannheim Corp.	2
Diazyme Laboratories, Inc.	2
Johnson & Johnson Clinical Diagnostics, Inc.	2
Leeco Diagnostics, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order