# CZP: Iga, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5510; FDA's rule: 510(k) required
- FDA decisions: 54
- Recalls: 1 (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)
- 1992: 1
- 1993: 1
- 1995: 1
- 1996: 3
- 1998: 1
- 2000: 1
- 2003: 1
- 2004: 1
- 2006: 1
- 2020: 1

## Most-cited predicates
- K771603: Immochemistry System (1977), cited by 7
- K955907: Boehringer Mannheim Iga Assay (1996), cited by 2
- K920014: IL Test Immunoglobulin a (1992), cited by 1
- K040435: Roche Diagnostics Tina-Quant Iga Gen.2 (2004), cited by 1
- K952309: N Latex Iga (1995), cited by 1

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