Phadia US, Inc. · Class II · Cleared Aug 13, 2010
| K-number | K093459 |
| Device name | ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 |
| Applicant | Phadia US, Inc. |
| Product code | MST |
| Device class | Class II |
| Decision date | Aug 13, 2010 |
| Decision | Substantially Equivalent |
| Regulation | 866.5750 |
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