Product code DFK— Immunology
ANTISERA TO HUMAN FAB FRAGMENT
- Classification name
- Igg (Fab Fragment Specific), Antigen, Antiserum, Control
- Device class
- Class 1
- Regulation
- 21 CFR 866.5520
- Advisory panel
- Immunology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code DFK
FDA has cleared devices under product code DFK between 1977 and 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.
Clearances per year
- 1979
- 1977
Top applicants under product code DFK
Recent clearances under product code DFK
Data sourced from openFDA. This site is unofficial and independent of the FDA.