KHPClass I

Acid, Lactic, Enzymatic Method

21 CFR 862.1450 / Clinical Chemistry

KHP is the FDA product code for Acid, Lactic, Enzymatic Method, a class I device type, regulated under 21 CFR 862.1450. As of 2026-09-10, FDA records hold 27 510(k) clearances under this code, the most recent dated 2013-03-11, and 19 recalls.

Classification record

Product code: KHP
Device name: Acid, Lactic, Enzymatic Method
Regulation: 21 CFR 862.1450
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: 27
Ingested recalls: 19

Clearances, product code KHP

By decision year

27 clearances under product code KHP with a decision year between 1979 and 2013, 1991 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code KHP by decision year
Year	Clearances
1979	1
1980	1
1984	1
1985	1
1986	1
1988	1
1989	1
1990	2
1991	4
1993	1
1995	2
1997	1
1998	2
2001	1
2002	1
2010	1
2011	2
2012	2
2013	1

Applicants with the most clearances

Product code KHP

Applicants holding the most 510(k) clearances under product code KHP
Applicant	Clearances
Nova Biomedical Corporation	3
E.I. Dupont de Nemours & Co., Inc.	2
Eastman Kodak Company	2
I-Stat Corp.	2
Yellow Springs Instrument Co., Inc.	2
Abaxis Inc	1
Abbott Medical	1
Abbott Pont of Care, Inc.	1
American Dade	1
Beckman Instruments, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 34 companies shown, in name order