# CZW: Complement C3, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5240; FDA's rule: 510(k) required
- FDA decisions: 44
- Recalls: 0 (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)
- 1998: 1
- 1999: 3
- 2000: 2
- 2001: 2
- 2003: 1
- 2004: 2
- 2005: 1
- 2006: 1
- 2007: 1
- 2010: 1

## Most-cited predicates
- K964842: Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4 (C4) Reagent (1997), cited by 2
- K964298: N-Assay Tia Multi V-NL (1997), cited by 1
- K050665: N Antisera to Human Complement Factors (C3C, C4) (2005), cited by 1
- K920007: IL Test Complement 3 (1992), cited by 1

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