510(k) K980249 ยท LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
| Applicant | Princeton BioMeditech Corp., Monmouth Junction NJ, US |
| Decision | Substantially Equivalent, Mar 13, 1998 |
| Received | Jan 23, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980249
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.