510(k) K152025
K152025 is an FDA 510(k) premarket notification submitted by Assure Tech. Co., Ltd. for the device "AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)". The FDA issued a decision of Substantially Equivalent on October 5, 2015. The device falls under product code DJR (Enzyme Immunoassay, Methadone), a Class II device regulated under 21 CFR 862.3620. Assure Tech. Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 2015
- Date Received
- July 22, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Methadone
- Device Class
- Class II
- Regulation Number
- 862.3620
- Review Panel
- TX
- Submission Type