510(k) K030067 ยท MJX Kit, Serological, Positive Control
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Jan 17, 2003 |
| Received | Jan 7, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030067
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2016 | Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598
For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITR Terminated |
MJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.