Panels › Clinical Chemistry › Product code MJX · Class 1
Kit, Serological, Positive Control
Regulation 862.1660
0510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MJX
| Company | 510(k)s | Recalls |
|---|---|---|
| Ortho-Clinical Diagnostics | 1 | 1 |
| Aalto Scientific, Ltd. | 1 | 0 |
| Boston Biomedica, Inc. | 1 | 0 |
| Pb Diagnostic Systems, Inc. | 1 | 0 |
| Pb Diagnostics, Inc. | 1 | 0 |
| Scantibodies Laboratory, Inc. | 1 | 0 |
| Simplicity Diagnostics, Inc. | 1 | 0 |
| 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 | K030067 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.