Product code MJZ— Clinical Chemistry
ABBOTT STREP A CONTROLS
- Classification name
- Kit, Direct Antigen, Positive Control
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code MJZ
FDA has cleared devices under product code MJZ between 1997 and 2009, filed by 3 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
- 2009
- 1997
Top applicants under product code MJZ
Recent clearances under product code MJZ
Data sourced from openFDA. This site is unofficial and independent of the FDA.