CICClass II

Cresolphthalein Complexone, Calcium

21 CFR 862.1145 / Clinical Chemistry

CIC is the FDA product code for Cresolphthalein Complexone, Calcium, a class II device type, regulated under 21 CFR 862.1145. As of 2026-09-10, FDA records hold 99 510(k) clearances under this code, the most recent dated 2013-05-02, and 10 recalls.

Classification record

Product code: CIC
Device name: Cresolphthalein Complexone, Calcium
Regulation: 21 CFR 862.1145
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: 99
Ingested recalls: 10

Clearances, product code CIC

By decision year

99 clearances under product code CIC with a decision year between 1976 and 2013, 1987 the highest year at 12.

Show the numbers

510(k) clearances under FDA product code CIC by decision year
Year	Clearances
1976	2
1977	4
1978	1
1979	1
1980	3
1981	3
1982	5
1983	6
1984	6
1985	7
1986	10
1987	12
1988	7
1989	5
1990	5
1991	1
1992	5
1993	1
1994	1
1995	1
1996	2
1997	1
1999	1
2000	1
2001	1
2003	1
2004	1
2005	1
2006	1
2007	1
2009	1
2013	1

Applicants with the most clearances

Product code CIC

Applicants holding the most 510(k) clearances under product code CIC
Applicant	Clearances
Em Diagnostic Systems, Inc.	7
Abbott Medical	3
American Research Products Co.	3
Boehringer Mannheim Corp.	3
Diagnostic Chemicals, Ltd. (USA)	3
Horiba Instruments Incorporated	3
Technicon Instruments Corp.	3
Advanced Biomedical Methods, Inc.	2
Amresco, Inc.	2
Arkray, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order