# MDK: Dna-Probe, Reagents, Streptococcal

- Device class: 1; regulation: 21 CFR 866.3740; FDA's rule: 510(k) exempt
- FDA decisions: 4
- Recalls: 2 (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)
- 1990: 1
- 1992: 1
- 1994: 1
- 1998: 1

## Most-cited predicates
- K924715: Gen-Probe Direct Group a Streptococus Test (1994), cited by 1

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