510(k) K233417
K233417 is an FDA 510(k) premarket notification submitted by Hangzhou AllTest Biotech Co., Ltd. for the device "AllTest Fentanyl Urine Test Cassette". The FDA issued a decision of Substantially Equivalent on October 26, 2023. The device falls under product code NGL (Test, Opiates, Over The Counter), a Class II device regulated under 21 CFR 862.3650. Hangzhou AllTest Biotech Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 2023
- Date Received
- October 10, 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