510(k) K150791 ยท DIS Enzyme Immunoassay, Barbiturate
Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
| Applicant | Healgen Scientific,, LLC, Bellaire TX, US |
| Decision | Substantially Equivalent, Apr 24, 2015 |
| Received | Mar 25, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150791
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.