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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 22, 2010 | K101434 | AUDIT MICROCV PROCALCITONIN LINEARITY Aalto Scientific, Ltd. | MJX |
| Jan 17, 2003 | K030067 | VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS Ortho-Clinical Diagnostics | MJX |
| Dec 24, 1997 | K974262 | SYSCOS IDC - G, IDC, BSC, IDC - G Scantibodies Laboratory, Inc. | MJX |
| Oct 8, 1997 | K972986 | ACCURUN 140 RUBELLA IGG POSITIVE CONTROL Boston Biomedica, Inc. | MJX |
| Mar 10, 1997 | K970100 | TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL Simplicity Diagnostics, Inc. | MJX |
| Mar 7, 1994 | K934137 | OPUS(R) SEROLOGY CONTROLS, MODIFICATION Pb Diagnostic Systems, Inc. | MJX |
| Apr 8, 1993 | K925703 | OPUS SEROLOGY CONTROLS Pb Diagnostics, Inc. | MJX |
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