510(k) K012257 ยท DKZ Enzyme Immunoassay, Amphetamine
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
| Applicant | Syva Co., Cupertino CA, US |
| Decision | Substantially Equivalent, Aug 3, 2001 |
| Received | Jul 18, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012257
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.