| K-number | K041238 |
| Device name | HELICOBACTER PYLORI IGG ELISA |
| Applicant | Biohit Plc |
| Product code | LYR |
| Device class | Class I |
| Decision date | Dec 13, 2004 |
| Decision | Substantially Equivalent |
| Regulation | — |
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