Elan Diagnostics
Medical device manufacturer in Brea, CA.
13510(k) clearances
0PMA approvals
0recalls
Device types
- CIG Diazo Colorimetry, Bilirubin 2
- LBR Ldl & Vldl Precipitation, Hdl 1
- CFR Hexokinase, Glucose 1
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 1
- MRR System, Test, Low Density, Lipoprotein 1
- CDQ Urease And Glutamic Dehydrogenase, Urea… 1
- CGX Alkaline Picrate, Colorimetry, Creatinine 1
- CIX Bromcresol Green Dye-Binding, Albumin 1
- CEO Phosphomolybdate (Colorimetric), Inorganic… 1
- JGJ Photometric Method, Magnesium 1
- CIC Cresolphthalein Complexone, Calcium 1
- JIX Calibrator, Multi-Analyte Mixture 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K030003 | Atac Direct Bilirubin Reagent and CalibratorCIG · Traditional | 09/29/2003SE |
| K030014 | Atac Total Bilirubin ReagentCIG · Traditional | 09/26/2003SE |
| K030621 | Atac CalibratorJIX · Traditional | 03/19/2003SE |
| K023105 | Atac Calcium Reagent and Atac CalibratorCIC · Traditional | 03/13/2003SE |
| K030010 | Atac Pak Magnesium ReagentJGJ · Traditional | 03/10/2003SE |
| K030015 | Atac Pak Phosphorus ReagentCEO · Traditional | 03/07/2003SE |
| K030006 | Atac Pak Albumin ReagentCIX · Traditional | 03/07/2003SE |
| K023407 | Atac Pak Creatinine Reagent and Atac CalibratorCGX · Traditional | 02/14/2003SE |
| K021385 | Atac Pak Bun ReagentCDQ · Traditional | 07/12/2002SE |
| K020575 | Atac Direct LDL Reagent and Atac Direct LDL Calibrator KitsMRR · Traditional | 04/12/2002SE |
| K002285 | Atac Pak Alp Reagent KitCJE · Traditional | 09/26/2000SE |
| K000556 | Atac Pak Glucose Reagent and Atac Calibrator KitsCFR · Traditional | 05/17/2000SE |
| K992029 | Atac Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator KitsLBR · Traditional | 08/12/1999SE |