510(k) K031797 ยท DJR Enzyme Immunoassay, Methadone
METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)
| Applicant | Lin-Zhi International, Inc., Synnyvale CA, US |
| Decision | Substantially Equivalent, Oct 10, 2003 |
| Received | Jun 10, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031797
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.