MJX — Kit, Serological, Positive Control Class I
FDA product code MJX covers "Kit, Serological, Positive Control", a Class I medical device regulated under 21 CFR 862.1660. Submissions are reviewed by the Clinical Chemistry panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MJX
- Device Class
- Class I
- Regulation Number
- 862.1660
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K101434 | aalto scientific | AUDIT MICROCV PROCALCITONIN LINEARITY | July 22, 2010 |
| K030067 | ortho-clinical diagnostics | VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS | January 17, 2003 |
| K974262 | scantibodies laboratory | SYSCOS IDC - G, IDC, BSC, IDC - G | December 24, 1997 |
| K972986 | boston biomedica | ACCURUN 140 RUBELLA IGG POSITIVE CONTROL | October 8, 1997 |
| K970100 | simplicity diagnostics | TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SER | March 10, 1997 |
| K934137 | pb diagnostic systems | OPUS(R) SEROLOGY CONTROLS, MODIFICATION | March 7, 1994 |
| K925703 | pb diagnostics | OPUS SEROLOGY CONTROLS | April 8, 1993 |