510(k) K141748 ยท DKZ Enzyme Immunoassay, Amphetamine
RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET
| Applicant | Biophor Diagnostics, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, May 20, 2015 |
| Received | Jun 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141748
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.