510(k) K014089 ยท DIS Enzyme Immunoassay, Barbiturate
VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES
| Applicant | Sun Biomedical Laboratories, Inc., Blackwood NJ, US |
| Decision | Substantially Equivalent, Apr 25, 2002 |
| Received | Dec 11, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K014089
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.