510(k) K141055 ยท DJG Enzyme Immunoassay, Opiates
LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)
| Applicant | Lin-Zhi International, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 13, 2014 |
| Received | Apr 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141055
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.