KHSClass II

Enzymatic, Carbon-Dioxide

21 CFR 862.1160 / Clinical Chemistry

KHS is the FDA product code for Enzymatic, Carbon-Dioxide, a class II device type, regulated under 21 CFR 862.1160. As of 2026-09-10, FDA records hold 86 510(k) clearances under this code, the most recent dated 2017-06-01, and 7 recalls.

Classification record

Product code: KHS
Device name: Enzymatic, Carbon-Dioxide
Regulation: 21 CFR 862.1160
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: 86
Ingested recalls: 7

Clearances, product code KHS

By decision year

86 clearances under product code KHS with a decision year between 1976 and 2017, 1988 the highest year at 11.

Show the numbers

510(k) clearances under FDA product code KHS by decision year
Year	Clearances
1976	1
1977	1
1981	1
1982	1
1984	3
1985	3
1986	2
1987	3
1988	11
1989	4
1990	8
1991	2
1992	2
1993	2
1994	2
1995	2
1996	4
1998	5
1999	3
2000	2
2001	3
2003	2
2004	1
2006	3
2007	2
2008	1
2009	1
2010	3
2011	1
2012	2
2013	2
2014	1
2016	1
2017	1

Applicants with the most clearances

Product code KHS

Applicants holding the most 510(k) clearances under product code KHS
Applicant	Clearances
Em Diagnostic Systems, Inc.	7
Abbott Medical	4
Boehringer Mannheim Corp.	4
Siemens Healthcare Diagnostics Inc.	4
Data Medical Associates, Inc.	4
Sekisui Diagnostics P.E.I. Inc.	4
Diagnostic Chemicals, Ltd. (USA)	3
Ortho-Clinical Diagnostics, Inc.	3
Horiba Instruments Incorporated	3
Trace America, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order