510(k) K821653 ยท LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
PROTRIPTYLINE TRI-CY TEST SET
| Applicant | Wien Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 14, 1982 |
| Received | Jun 3, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821653
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.