510(k) K180349
K180349 is an FDA 510(k) premarket notification submitted by Assure Tech. (Hangzhou) Co, Ltd. for the device "AssureTech Panel Dip Tests, AssureTech Quick Cup Tests". The FDA issued a decision of Substantially Equivalent on April 5, 2018. The device falls under product code NFT (Test, Amphetamine, Over The Counter), a Class II device regulated under 21 CFR 862.3100. Assure Tech. (Hangzhou) Co, Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2018
- Date Received
- February 8, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Amphetamine, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.3100
- Review Panel
- TX
- Submission Type