FDA Product Code
FDA Product Code MJX — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1660
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K101434 | AUDIT MICROCV PROCALCITONIN LINEARITY | Aalto Scientific, Ltd. | 2010-07-22 | Traditional | PDF ↗ |
| K030067 | VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS | Ortho-Clinical Diagnostics | 2003-01-17 | Traditional | PDF ↗ |
| K974262 | SYSCOS IDC - G, IDC, BSC, IDC - G | Scantibodies Laboratory, Inc. | 1997-12-24 | Traditional | PDF ↗ |
| K972986 | ACCURUN 140 RUBELLA IGG POSITIVE CONTROL | Boston Biomedica, Inc. | 1997-10-08 | Traditional | PDF ↗ |
| K970100 | TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL | Simplicity Diagnostics, Inc. | 1997-03-10 | Traditional | PDF ↗ |
| K934137 | OPUS(R) SEROLOGY CONTROLS, MODIFICATION | Pb Diagnostic Systems, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K925703 | OPUS SEROLOGY CONTROLS | Pb Diagnostics, Inc. | 1993-04-08 | Traditional | PDF ↗ |
Product code MJX · Class I · Clinical Chemistry. Data: openFDA.