KNKClass I

Acid, Uric, Uricase (Colorimetric)

21 CFR 862.1775 / Clinical Chemistry

KNK is the FDA product code for Acid, Uric, Uricase (Colorimetric), a class I device type, regulated under 21 CFR 862.1775. As of 2026-09-10, FDA records hold 118 510(k) clearances under this code, the most recent dated 2011-05-06, and 15 recalls.

Classification record

Product code: KNK
Device name: Acid, Uric, Uricase (Colorimetric)
Regulation: 21 CFR 862.1775
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: 118
Ingested recalls: 15

Clearances, product code KNK

By decision year

118 clearances under product code KNK with a decision year between 1977 and 2011, 1986 the highest year at 11.

Show the numbers

510(k) clearances under FDA product code KNK by decision year
Year	Clearances
1977	2
1978	2
1979	4
1980	6
1981	10
1982	5
1983	6
1984	10
1985	5
1986	11
1987	7
1988	4
1989	8
1990	9
1991	2
1992	5
1993	3
1994	2
1996	2
1997	4
1998	1
1999	2
2001	2
2002	1
2003	2
2004	1
2007	1
2011	1

Applicants with the most clearances

Product code KNK

Applicants holding the most 510(k) clearances under product code KNK
Applicant	Clearances
Em Diagnostic Systems, Inc.	6
Boehringer Mannheim Corp.	5
Abbott Medical	4
Roche Diagnostic Systems, Inc.	4
FUJIFILM Healthcare Americas Corporation	4
Clinical Data, Inc.	3
Data Medical Associates, Inc.	3
Technicon Instruments Corp.	3
Alpkem Corp.	2
American Research Products Co.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 39 companies shown, in name order