MJX
7 FDA 510(k) clearances · Product code
59 daysmedian time to decision
194 days90th percentile
7clearances measured
FDA profile
- Official device name
- Kit, Serological, Positive Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Medical specialty
- Clinical Chemistry
- Adverse events (MAUDE)
- 2006: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AUDIT MICROCV PROCALCITONIN LINEARITY (K101434) | Aalto Scientific, Ltd. | 2010-07-22 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS (K030067) | Ortho-Clinical Diagnostics | 2003-01-17 |
| SYSCOS IDC - G, IDC, BSC, IDC - G (K974262) | Scantibodies Laboratory, Inc. | 1997-12-24 |
| ACCURUN 140 RUBELLA IGG POSITIVE CONTROL (K972986) | Boston Biomedica, Inc. | 1997-10-08 |
| TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL (K970100) | Simplicity Diagnostics, Inc. | 1997-03-10 |
| OPUS(R) SEROLOGY CONTROLS, MODIFICATION (K934137) | Pb Diagnostic Systems, Inc. | 1994-03-07 |
| OPUS SEROLOGY CONTROLS (K925703) | Pb Diagnostics, Inc. | 1993-04-08 |
Track MJX automatically
Every clearance here is in the API, with alerts when new ones post.