# Elan Holdings, Inc.

- Location (FDA's records): Brea, CA
- FDA decisions: 12 (1999–2001): 12 510(k) clearances
- Product codes: JGS (2), LBS (1), JIX (1), CEK (1), CGS (1), CHH (1), LFP (1), LBR (1), CDQ (1), CIT (1), CJE (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
- K013152: Atac Pak Direct HDL Reagent and Atac Direct HDL Calibrator Kits (Nov 9, 2001)
- K012474: Atac Pak CPK Reagent Kit (Oct 3, 2001)
- K010488: Atac Pak Ast Reagent Kit (Apr 9, 2001)
- K000958: Atac Pak Bun Reagent and Atac Calibrator Kits (May 24, 2000)
- K000900: Atac Pak Cholesterol Reagent and Atac Callibrator Kits (May 2, 2000)
- K992842: Hichem Ise Electrolyte Reference (Nov 26, 1999)
- K992844: Hichem Ise Electrolyte Buffer (Nov 26, 1999)
- K992845: Hichem Calibrator 1 Kit, Hichem Calibrator 2 Kit, Hichem Calibrator 3 Kit, Calibration Standards Kit (Oct 18, 1999)

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