510(k) K234006
K234006 is an FDA 510(k) premarket notification submitted by Allsource Screening Solutions for the device "AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test". The FDA issued a decision of Substantially Equivalent on March 21, 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
- March 21, 2024
- Date Received
- December 19, 2023
- 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