Product code GOX— Microbiology
AGGLUTINOTEST-PERTUSSIS
- Classification name
- Antigen, B. Pertussis
- Device class
- Class 1
- Regulation
- 21 CFR 866.3065
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code GOX
FDA has cleared device under product code GOX, all in 1979, 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 GOX
Recent clearances under product code GOX
Data sourced from openFDA. This site is unofficial and independent of the FDA.