# LJZ: Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.

- Device class: 1; regulation: 21 CFR 866.3375; FDA's rule: 510(k) exempt
- FDA decisions: 13
- Recalls: 3 (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)
- 1983: 1
- 1989: 2
- 1991: 1
- 1992: 2
- 1994: 1
- 1997: 5
- 1999: 1

## Most-cited predicates

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