# MJM: Dna Probe, Gardnerella Vaginalis

- Device class: 1; regulation: 21 CFR 866.2660; FDA's rule: 510(k) exempt
- FDA decisions: 2
- 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)
- 1992: 1
- 1997: 1

## Most-cited predicates
- K964015: Indicard Test (1997), cited by 1
- K923133: Affirm/VP Ident.Test G.Vaginalis & T.Vaginalis (1992), cited by 1

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