Elan Holdings, Inc. · Class I · Cleared May 2, 2000
| K-number | K000900 |
| Device name | ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS |
| Applicant | Elan Holdings, Inc. |
| Product code | CHH |
| Device class | Class I |
| Decision date | May 2, 2000 |
| Decision | Substantially Equivalent |
| Regulation | 862.1175 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov