510(k) K101195 ยท DJG Enzyme Immunoassay, Opiates
6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS
| Applicant | Lin-Zhi International, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jul 6, 2010 |
| Received | Apr 29, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101195
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.