| K-number | K905531 |
| Device name | LUPUS(LE)-LATEX TEST |
| Applicant | Immco Diagnostics, Inc. |
| Product code | LKI |
| Device class | Class I |
| Decision date | Jan 25, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 866.3120 |
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