Product code MJX— Clinical Chemistry
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
- Classification name
- Kit, Serological, Positive Control
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Total cleared
- 7
- First cleared
- Most recent
Market context for product code MJX
FDA has cleared devices under product code MJX between 1993 and 2010, filed by 7 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2010
- 2003
- 1997
- 1994
- 1993
Top applicants under product code MJX
Recent clearances under product code MJX
- K101434 — AUDIT MICROCV PROCALCITONIN LINEARITY
- K030067 — VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
- K974262 — SYSCOS IDC - G, IDC, BSC, IDC - G
- K972986 — ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
- K970100 — TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
- K934137 — OPUS(R) SEROLOGY CONTROLS, MODIFICATION
- K925703 — OPUS SEROLOGY CONTROLS
Data sourced from openFDA. This site is unofficial and independent of the FDA.