510(k) K011545 ยท LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
VERDICT -II TCA, VERDICT-II MTD
| Applicant | Medtox Diagnostics, Inc., Burlington NC, US |
| Decision | Substantially Equivalent, Jun 8, 2001 |
| Received | May 18, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011545
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.