Diazyme Laboratories · Class II · Cleared Dec 5, 2008
| K-number | K082001 |
| Device name | DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B |
| Applicant | Diazyme Laboratories |
| Product code | JII |
| Device class | Class II |
| Decision date | Dec 5, 2008 |
| Decision | Substantially Equivalent |
| Regulation | 862.3560 |
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