# LIB: Device, General Purpose, Microbiology, Diagnostic

- Device class: 1; regulation: 21 CFR 866.2660; FDA's rule: 510(k) exempt
- FDA decisions: 43
- Recalls: 6 (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)
- 1981: 1
- 1982: 8
- 1983: 10
- 1984: 6
- 1985: 10
- 1986: 2
- 1987: 3
- 1991: 1
- 1992: 1
- 2003: 1

## Most-cited predicates

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