510(k) K062565 ยท MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites
STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE
| Applicant | Princeton BioMeditech Corp., Monmouth Junction NJ, US |
| Decision | Substantially Equivalent, Feb 20, 2007 |
| Received | Aug 31, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062565
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.