510(k) K143187 ยท DJG Enzyme Immunoassay, Opiates
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)
| Applicant | Healgen Scientific,, LLC, Bellaire TX, US |
| Decision | Substantially Equivalent, Jan 27, 2015 |
| Received | Nov 5, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143187
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.