| K-number | K860665 |
| Device name | ALPHA-AMYLASE TEST |
| Applicant | Sclavo, Inc. |
| Product code | JFJ |
| Device class | Class II |
| Decision date | Apr 7, 1986 |
| Decision | Substantially Equivalent |
| Regulation | 862.1070 |
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