510(k) K102210 ยท DKZ Enzyme Immunoassay, Amphetamine
LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS
| Applicant | Lin-Zhi International, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 28, 2010 |
| Received | Aug 5, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102210
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.