Product code DBN— Immunology
QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK
- Classification name
- Fc, Antigen, Antiserum, Control
- Device class
- Class 1
- Regulation
- 21 CFR 866.5530
- Advisory panel
- Immunology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code DBN
FDA has cleared device under product code DBN, all in 1989, 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 DBN
Recent clearances under product code DBN
Data sourced from openFDA. This site is unofficial and independent of the FDA.