# LRG: Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

- Device class: 2; regulation: 21 CFR 866.1640; FDA's rule: 510(k) required
- FDA decisions: 45
- 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)
- 1994: 1
- 1998: 1
- 2004: 2
- 2005: 3
- 2006: 18
- 2007: 1
- 2008: 1
- 2010: 1
- 2011: 4
- 2019: 2

## Most-cited predicates
- K062923: Microscan Microstrep Plus Panel Tetracycline (0.006 to 16 MCG/ML) (2006), cited by 1

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