K153465 is an FDA 510(k) clearance for the 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). This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).
Submitted by Assure Tech. (Hangzhou) Co, Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on March 31, 2016, 121 days after receiving the submission on December 1, 2015.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K153465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2015 |
| Decision Date | March 31, 2016 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DKZ — Enzyme Immunoassay, Amphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3100 |