510(k) K151348 ยท LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)
| Applicant | Healgen Scientific,, LLC, Bellaire TX, US |
| Decision | Substantially Equivalent, Aug 18, 2015 |
| Received | May 20, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151348
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.