| K-number | K982391 |
| Device name | REAADS IGG ANTI-B2GPI TEST KIT |
| Applicant | Corgenix, Inc. |
| Product code | MSV |
| Device class | Class II |
| Decision date | Dec 7, 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