# LIG: Radioassay, Intrinsic Factor Blocking Antibody

- Device class: 2; regulation: 21 CFR 862.1810; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 39 days (middle half 39–39)
- 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)
- 1982: 1
- 1990: 1
- 1999: 2
- 2003: 1
- 2006: 1
- 2007: 1
- 2024: 1

## Most-cited predicates
- K984108: Abbott Architect B12 (1999), cited by 1
- K033603: Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems, Models 387992, 387993, 387999 (2003), cited by 1
- K993251: Immulite 2000 Vitamin B12, Model L2KVB2, L2KVB6 (1999), cited by 1
- K811927: 1F Blocking Antibody (57 CO) Radioassay (1982), cited by 1

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