# GMS: Anti-Human Globulin, Fta-Abs Test

- Device class: 2; regulation: 21 CFR 866.3830; FDA's rule: 510(k) required
- FDA decisions: 3
- 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)
- 1978: 1
- 1984: 1
- 1985: 1

## Most-cited predicates

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