DIHClass I

Colorimetry, Cholinesterase

21 CFR 862.3240 / Clinical Toxicology

DIH is the FDA product code for Colorimetry, Cholinesterase, a class I device type, regulated under 21 CFR 862.3240. As of 2026-09-10, FDA records hold 26 510(k) clearances under this code, the most recent dated 2011-02-07, and 5 recalls.

Classification record

Product code: DIH
Device name: Colorimetry, Cholinesterase
Regulation: 21 CFR 862.3240
Device class: Class I
Review panel: Clinical Toxicology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 26
Ingested recalls: 5

Clearances, product code DIH

By decision year

26 clearances under product code DIH with a decision year between 1979 and 2011, 1989 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code DIH by decision year
Year	Clearances
1979	1
1986	4
1988	1
1989	5
1991	4
1996	3
2000	2
2002	1
2003	2
2005	1
2006	1
2011	1

Applicants with the most clearances

Product code DIH

Applicants holding the most 510(k) clearances under product code DIH
Applicant	Clearances
Sclavo, Inc.	3
Eastman Kodak Company	2
Sigma Diagnostics, Inc.	2
Bayer Corp.	1
Bayer Diagnostics Corp.	1
Beckman	1
Siemens Healthcare Diagnostics Inc.	1
Careside, Inc.	1
Crestat Diagnostics, Inc.	1
Sekisui Diagnostics P.E.I. Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order