# Elan Diagnostics

- Location (FDA's records): Brea, CA
- FDA decisions: 13 (1999–2003): 13 510(k) clearances
- Product codes: CIG (2), CGX (1), CJE (1), JGJ (1), JIX (1), CEO (1), LBR (1), MRR (1), CIC (1), CFR (1), CDQ (1), CIX (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K030003: Atac Direct Bilirubin Reagent and Calibrator (Sep 29, 2003)
- K030014: Atac Total Bilirubin Reagent (Sep 26, 2003)
- K030621: Atac Calibrator (Mar 19, 2003)
- K023105: Atac Calcium Reagent and Atac Calibrator (Mar 13, 2003)
- K030010: Atac Pak Magnesium Reagent (Mar 10, 2003)
- K030015: Atac Pak Phosphorus Reagent (Mar 7, 2003)
- K030006: Atac Pak Albumin Reagent (Mar 7, 2003)
- K023407: Atac Pak Creatinine Reagent and Atac Calibrator (Feb 14, 2003)

Source page: https://510kreport.com/company/elan-diagnostics