510(k) K063398 ยท DIF Drug Mixture Control Materials
ESA LEADCARE II LEAD CONTROL
| Applicant | Bionostics, Inc., Devens MA, US |
| Decision | Substantially Equivalent, Dec 5, 2006 |
| Received | Nov 9, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063398
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.