Shield Diagnostics, Ltd. · Class II · Cleared Mar 6, 1995
| K-number | K942813 |
| Device name | DIASTAT ANTI-PR3 (C-ANCA) KIT |
| Applicant | Shield Diagnostics, Ltd. |
| Product code | MOB |
| Device class | Class II |
| Decision date | Mar 6, 1995 |
| 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