| K-number | K113377 |
| Device name | GLIADIN IGA AND GLIADIN LGA |
| Applicant | Grifols USA, LLC |
| Product code | MST |
| Device class | Class II |
| Decision date | Dec 14, 2012 |
| 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