510(k) K935565 ยท DJG Enzyme Immunoassay, Opiates
OPIATES MICRO-PLATE ASSAY
| Applicant | Solarcare Technologies Corp,Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Jul 14, 1995 |
| Received | Nov 18, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935565
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.