510(k) K002776 ยท LCM Enzyme Immunoassay, Phencyclidine
MODIFICATION TO PROFILE -II
| Applicant | Medtox Diagnostics, Inc., Burlington NC, US |
| Decision | Substantially Equivalent, Sep 28, 2000 |
| Received | Sep 6, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002776
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.