510(k) K153465
AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) by
Assure Tech. (Hangzhou) Co, Ltd.
— Product Code DKZ
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2016
- Date Received
- December 1, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Amphetamine
- Device Class
- Class II
- Regulation Number
- 862.3100
- Review Panel
- TX
- Submission Type