510(k) K133642 ยท DJG Enzyme Immunoassay, Opiates
RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK
| Applicant | Biophor Diagnostics, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Jan 24, 2014 |
| Received | Nov 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133642
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.