CEKClass II

Biuret (Colorimetric), Total Protein

21 CFR 862.1635 / Clinical Chemistry

CEK is the FDA product code for Biuret (Colorimetric), Total Protein, a class II device type, regulated under 21 CFR 862.1635. As of 2026-09-10, FDA records hold 116 510(k) clearances under this code, the most recent dated 1999-10-18, and 10 recalls.

Classification record

Product code: CEK
Device name: Biuret (Colorimetric), Total Protein
Regulation: 21 CFR 862.1635
Device class: Class II
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: 116
Ingested recalls: 10

Clearances, product code CEK

By decision year

116 clearances under product code CEK with a decision year between 1976 and 1999, 1986 the highest year at 12.

Show the numbers

510(k) clearances under FDA product code CEK by decision year
Year	Clearances
1976	3
1977	6
1978	2
1979	5
1980	5
1981	5
1982	5
1983	3
1984	8
1985	10
1986	12
1987	4
1988	6
1989	6
1990	6
1991	6
1992	8
1993	2
1994	4
1995	3
1996	3
1997	1
1998	2
1999	1

Applicants with the most clearances

Product code CEK

Applicants holding the most 510(k) clearances under product code CEK
Applicant	Clearances
Em Diagnostic Systems, Inc.	10
Harleco	6
Beckman Instruments, Inc.	4
Data Medical Associates, Inc.	4
Medical Analysis Systems, Inc.	3
FUJIFILM Healthcare Americas Corporation	3
Abbott Medical	2
American Monitor Corp.	2
American Research Products Co.	2
Amresco, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 36 companies shown, in name order