510(k) K201630
K201630 is an FDA 510(k) premarket notification submitted by Assure Tech. (Hangzhou) Co, Ltd. for the device "AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests". The FDA issued a decision of Substantially Equivalent on August 12, 2021. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Assure Tech. (Hangzhou) Co, Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2021
- Date Received
- June 16, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Opiates
- Device Class
- Class II
- Regulation Number
- 862.3650
- Review Panel
- TX
- Submission Type