CDTClass I

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

21 CFR 862.1705 / Clinical Chemistry

CDT is the FDA product code for Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, a class I device type, regulated under 21 CFR 862.1705. As of 2026-09-10, FDA records hold 151 510(k) clearances under this code, the most recent dated 2015-08-06, and 20 recalls.

Classification record

Product code: CDT
Device name: Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Regulation: 21 CFR 862.1705
Device class: Class I
Review panel: Clinical Chemistry
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 151
Ingested recalls: 20

Clearances, product code CDT

By decision year

151 clearances under product code CDT with a decision year between 1976 and 2015, 1986 the highest year at 16.

Show the numbers

510(k) clearances under FDA product code CDT by decision year
Year	Clearances
1976	6
1977	9
1978	5
1979	6
1980	7
1981	9
1982	4
1983	8
1984	13
1985	7
1986	16
1987	9
1988	6
1989	5
1990	6
1991	4
1992	6
1993	3
1994	1
1995	1
1996	5
1997	4
1999	1
2001	1
2002	1
2004	1
2005	1
2007	1
2011	1
2012	1
2013	2
2015	1

Applicants with the most clearances

Product code CDT

Applicants holding the most 510(k) clearances under product code CDT
Applicant	Clearances
Em Diagnostic Systems, Inc.	13
Boehringer Mannheim Corp.	6
Data Medical Associates, Inc.	6
Beckman Instruments, Inc.	4
Reagents Applications, Inc.	4
Simmler & Son, Inc.	4
Trace Scientific, Ltd.	4
Abbott Medical	3
BD Becton Dickinson Vacutainer Systems Preanalytic	3
Coulter Electronics, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order