| K-number | K802508 |
| Device name | RUBELISA IGM TEST KIT |
| Applicant | M.A. Bioproducts |
| Product code | GOL |
| Device class | Class II |
| Decision date | Dec 18, 1980 |
| Decision | Substantially Equivalent |
| Regulation | 866.3510 |
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