Assure Tech. (Hangzhou) Co, Ltd. · Class II · Cleared Mar 31, 2016
| K-number | K153465 |
| Device name | 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) |
| Applicant | Assure Tech. (Hangzhou) Co, Ltd. |
| Product code | DKZ |
| Device class | Class II |
| Decision date | Mar 31, 2016 |
| Decision | Substantially Equivalent |
| Regulation | 862.3100 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov