510(k) K981314 ยท DJR Enzyme Immunoassay, Methadone
VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE
| Applicant | Sun Biomedical Laboratories, Inc., Blackwood NJ, US |
| Decision | Substantially Equivalent, Sep 4, 1998 |
| Received | Apr 10, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981314
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.