| K-number | K970302 |
| Device name | APO-TEK LP(A) |
| Applicant | Perimmune, Inc. |
| Product code | DFC |
| Device class | Class II |
| Decision date | Nov 10, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 866.5600 |
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