510(k) K943248 ยท DJG Enzyme Immunoassay, Opiates
VISUALINE II MORPHINE/OPIATES/HEROIN
| Applicant | Sun Biomedical Laboratories, Inc., Cherry Hill NJ, US |
| Decision | Substantially Equivalent, Jan 30, 1995 |
| Received | Jul 6, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943248
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.