510(k) K163220 ยท LCM Enzyme Immunoassay, Phencyclidine
Atellica CH Phencyclidine (Pcp)
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Apr 6, 2017 |
| Received | Nov 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163220
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.