510(k) K983268 ยท LFH U.V. Spectrometry, Tricyclic Antidepressant Drugs
MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY
| Applicant | Diagnostic Reagents, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Nov 18, 1998 |
| Received | Sep 17, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983268
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.