Device Listing 1158331719
Listing Summary#
- Listing key
- 1158331719
- Premarket submission
- K240949
- Device
- 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
- Decision date
- 2024-05-13