510(k) K963733 ยท MRS Test System, Nicotine, Cotinine, Metabolites
NICCHECK I
| Applicant | Dynagen, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Dec 13, 1996 |
| Received | Sep 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963733
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.