Product code GNJ— Microbiology
BERA SH 221 BRIAN STEM AUDIOMETER
- Classification name
- Antigens, Ha, Echovirus 1-34
- Device class
- Class 1
- Regulation
- 21 CFR 866.3205
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code GNJ
FDA has cleared device under product code GNJ, all in 1983, filed by 1 applicant company. 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.
Top applicants under product code GNJ
Recent clearances under product code GNJ
Data sourced from openFDA. This site is unofficial and independent of the FDA.