510(k) K153465 ยท DKZ Enzyme Immunoassay, Amphetamine
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., Hangzhou, CN |
| Decision | Substantially Equivalent, Mar 31, 2016 |
| Received | Dec 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153465
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.