CDQClass II

Urease And Glutamic Dehydrogenase, Urea Nitrogen

21 CFR 862.1770 / Clinical Chemistry

CDQ is the FDA product code for Urease And Glutamic Dehydrogenase, Urea Nitrogen, a class II device type, regulated under 21 CFR 862.1770. As of 2026-09-10, FDA records hold 117 510(k) clearances under this code, the most recent dated 2022-05-31, and 6 recalls.

Classification record

Product code: CDQ
Device name: Urease And Glutamic Dehydrogenase, Urea Nitrogen
Regulation: 21 CFR 862.1770
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: 117
Ingested recalls: 6

Clearances, product code CDQ

By decision year

117 clearances under product code CDQ with a decision year between 1976 and 2022, 1986 the highest year at 8.

Show the numbers

510(k) clearances under FDA product code CDQ by decision year
Year	Clearances
1976	2
1977	3
1978	3
1979	1
1980	6
1981	4
1982	3
1983	7
1984	7
1985	7
1986	8
1987	6
1988	3
1989	7
1990	4
1991	2
1992	4
1993	5
1995	4
1996	2
1997	6
1998	5
1999	3
2000	3
2001	3
2002	1
2003	1
2004	1
2006	1
2007	1
2008	1
2011	1
2014	1
2022	1

Applicants with the most clearances

Product code CDQ

Applicants holding the most 510(k) clearances under product code CDQ
Applicant	Clearances
Em Diagnostic Systems, Inc.	9
Sigma Diagnostics, Inc.	5
Abbott Medical	4
Boehringer Mannheim Corp.	4
EMD Millipore Corporation	4
American Research Products Co.	3
Data Medical Associates, Inc.	3
Sekisui Diagnostics P.E.I. Inc.	3
Diagnostic Chemicals, Ltd. (USA)	3
Olympus Corp.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order