# Meridian Bioscience Israel, Ltd.

- Location (FDA's records): Modiin, IL
- FDA decisions: 3 (2022–2022): 3 510(k) clearances
- Product codes: MSQ (3)
- 510(k) review time since 2016: median 121 days, against 121 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Exalenz Bioscience, Ltd.: 3 (https://510kreport.com/company/exalenz-bioscience)

## Its most-cited devices
- K220494: BreathID Hp Lab System, BreathID Smart System (2022), cited by 1

## Recent decisions
- K221896: BreathID Hp System (Dec 19, 2022)
- K223185: BreathID®  Smart System (Nov 10, 2022)
- K220494: BreathID Hp Lab System, BreathID Smart System (Jun 23, 2022)

Source page: https://510kreport.com/company/meridian-bioscience-israel