CIXClass II

Bromcresol Green Dye-Binding, Albumin

21 CFR 862.1035 / Clinical Chemistry

CIX is the FDA product code for Bromcresol Green Dye-Binding, Albumin, a class II device type, regulated under 21 CFR 862.1035. As of 2026-09-10, FDA records hold 120 510(k) clearances under this code, the most recent dated 2026-01-09, and 6 recalls.

Classification record

Product code: CIX
Device name: Bromcresol Green Dye-Binding, Albumin
Regulation: 21 CFR 862.1035
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: 120
Ingested recalls: 6

Clearances, product code CIX

By decision year

120 clearances under product code CIX with a decision year between 1976 and 2026, 1986 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code CIX by decision year
Year	Clearances
1976	5
1977	8
1978	3
1979	2
1980	5
1981	4
1982	4
1983	5
1984	7
1985	9
1986	10
1987	4
1988	5
1989	4
1990	4
1991	4
1992	3
1993	2
1994	1
1995	2
1996	1
1997	1
1998	3
1999	3
2000	1
2001	3
2002	2
2003	2
2007	1
2008	1
2009	1
2011	3
2012	1
2013	1
2018	1
2019	1
2021	2
2026	1

Applicants with the most clearances

Product code CIX

Applicants holding the most 510(k) clearances under product code CIX
Applicant	Clearances
Em Diagnostic Systems, Inc.	9
Harleco	5
Abbott Medical	4
Data Medical Associates, Inc.	3
Technicon Instruments Corp.	3
Trace Scientific, Ltd.	3
Alfa Wassermann Diagnostic Technologies, Inc.	2
Amresco, Inc.	2
Bayer Corp.	2
Diagnostic Chemicals, Ltd. (USA)	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order