510(k) K120761 ยท DJG Enzyme Immunoassay, Opiates
LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS
| Applicant | Lin-Zhi International, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, May 8, 2012 |
| Received | Mar 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120761
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.