Immunalysis Corporation · Class II · Cleared Jun 14, 2017
| K-number | K161216 |
| Device name | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators |
| Applicant | Immunalysis Corporation |
| Product code | DJG |
| Device class | Class II |
| Decision date | Jun 14, 2017 |
| Decision | Substantially Equivalent |
| Regulation | 862.3650 |
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