Shield Diagnostics, Ltd. · Class II · Cleared Oct 15, 1998
| K-number | K982879 |
| Device name | SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY |
| Applicant | Shield Diagnostics, Ltd. |
| Product code | MSV |
| Device class | Class II |
| Decision date | Oct 15, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 866.5660 |
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