# CIC: Cresolphthalein Complexone, Calcium

- Device class: 2; regulation: 21 CFR 862.1145; FDA's rule: 510(k) required
- FDA decisions: 99
- Recalls: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1999: 1
- 2000: 1
- 2001: 1
- 2003: 1
- 2004: 1
- 2005: 1
- 2006: 1
- 2007: 1
- 2009: 1
- 2013: 1

## Most-cited predicates
- K070249: Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/H (2007), cited by 6
- K850281: Calcium (1985), cited by 3
- K896224: Cobas Ready Calcium Reagent (1990), cited by 2
- K921625: Calcium-Arsenazo Iii Reagent Set (1992), cited by 1
- K864741: Cresolphthalein Complexone, Calcium (1987), cited by 1
- K963292: Cobas Integra Reagent Cassettes & Ancillary Reagents (1996), cited by 1

Source page: https://510kreport.com/product-code/CIC
Data by year (CSV): https://510kreport.com/product-code/CIC.csv