510(k) K243064
K243064 is an FDA 510(k) premarket notification submitted by Eterbio, Inc. for the device "ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test". The FDA issued a decision of Substantially Equivalent on November 20, 2024. The device falls under product code NGL (Test, Opiates, Over The Counter), a Class II device regulated under 21 CFR 862.3650.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2024
- Date Received
- September 27, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Opiates, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.3650
- Review Panel
- TX
- Submission Type