510(k) K011499 ยท DKZ Enzyme Immunoassay, Amphetamine
VISUALINE AMPHETAMINE DIPSTRIP ASSAY
| Applicant | Sun Biomedical Laboratories, Inc., Blackwood NJ, US |
| Decision | Substantially Equivalent, Jul 17, 2001 |
| Received | May 15, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011499
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.