510(k) K033094 ยท DKZ Enzyme Immunoassay, Amphetamine
ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)
| Applicant | Lin-Zhi International, Inc., Synnyvale CA, US |
| Decision | Substantially Equivalent, Dec 19, 2003 |
| Received | Sep 29, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033094
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.