510(k) K921328 ยท DJG Enzyme Immunoassay, Opiates
STC DIAGNOSTICS AUTO-LYTE OPIATE EIA
| Applicant | Solarcare Technologies Corp,Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Aug 20, 1992 |
| Received | Mar 18, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921328
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.