Product code DEN— Immunology
GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID
- Classification name
- Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control
- Device class
- Class 1
- Regulation
- 21 CFR 866.5420
- Advisory panel
- Immunology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code DEN
FDA has cleared devices under product code DEN between 1977 and 1978, filed by 2 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
- 1978
- 1977
Top applicants under product code DEN
Recent clearances under product code DEN
Data sourced from openFDA. This site is unofficial and independent of the FDA.