510(k) K010177 ยท DKZ Enzyme Immunoassay, Amphetamine
VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY
| Applicant | Sun Biomedical Laboratories, Inc., Blackwood NJ, US |
| Decision | Substantially Equivalent, May 17, 2001 |
| Received | Jan 18, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010177
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.