510(k) K153597 ยท JXM Enzyme Immunoassay, Benzodiazepine
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
| Applicant | Healgen Scientific,, LLC, Bellaire TX, US |
| Decision | Substantially Equivalent, May 23, 2016 |
| Received | Dec 16, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153597
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.