Healgen Scientific,, LLC · Class II · Cleared May 13, 2024
| K-number | K240949 |
| Device name | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) |
| Applicant | Healgen Scientific,, LLC |
| Product code | NGL |
| Device class | Class II |
| Decision date | May 13, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 862.3650 |
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