510(k) K131653 ยท DKZ Enzyme Immunoassay, Amphetamine
LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
| Applicant | Lin-Zhi International, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 4, 2014 |
| Received | Jun 5, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131653
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.