# JTZ: Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

- Device class: 2; regulation: 21 CFR 866.1700; FDA's rule: 510(k) required
- FDA decisions: 75
- Recalls: 7 (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)
- 1984: 10
- 1985: 12
- 1986: 2
- 1987: 7
- 1988: 2
- 1994: 1
- 1995: 1
- 1996: 3
- 2014: 1
- 2026: 1

## Most-cited predicates
- K863821: Mueller Hinton Agar W/4%Nacl and Oxacillin (1986), cited by 5
- K850291: Mueller Hinton Agar W/4% Nacl W/Antibiotics (1985), cited by 3
- K963036: Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood (1996), cited by 1
- K960420: Mueller Hinton Agar with 5% Sheep Blood (1996), cited by 1

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