# GMD: Antisera, Latex Agglutination, Cryptococcus Neoformans

- Device class: 2; regulation: 21 CFR 866.3165; FDA's rule: 510(k) exempt
- FDA decisions: 10
- 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)
- 1978: 1
- 1979: 1
- 1980: 1
- 1981: 2
- 1989: 1
- 1993: 1
- 1994: 1
- 2011: 1
- 2012: 1

## Most-cited predicates
- K791382: Cryptococcal Antigen Latex Agglutination (1979), cited by 1
- K102286: Crag Lateral Flow Assay (Crag Lfa) (2011), cited by 1

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