Elan Diagnostics
Elan Diagnostics appears in FDA public data with 0 recalls, 13 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on September 29, 2003.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 13
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K030003 | ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR | September 29, 2003 |
| K030014 | ATAC TOTAL BILIRUBIN REAGENT | September 26, 2003 |
| K030621 | ATAC CALIBRATOR | March 19, 2003 |
| K023105 | ATAC CALCIUM REAGENT AND ATAC CALIBRATOR | March 13, 2003 |
| K030010 | ATAC PAK MAGNESIUM REAGENT | March 10, 2003 |
| K030015 | ATAC PAK PHOSPHORUS REAGENT | March 7, 2003 |
| K030006 | ATAC PAK ALBUMIN REAGENT | March 7, 2003 |
| K023407 | ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR | February 14, 2003 |
| K021385 | ATAC PAK BUN REAGENT | July 12, 2002 |
| K020575 | ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS | April 12, 2002 |
| K002285 | ATAC PAK ALP REAGENT KIT | September 26, 2000 |
| K000556 | ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS | May 17, 2000 |
| K992029 | ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS | August 12, 1999 |