510(k) K141205 ยท DJG Enzyme Immunoassay, Opiates
LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6
| Applicant | Lin-Zhi International, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 13, 2015 |
| Received | May 9, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141205
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.