Product code DJK— Clinical Toxicology
DIGITOXIN
- Classification name
- Digitoxin Control Serum, Ria
- Device class
- Class 1
- Regulation
- 21 CFR 862.3280
- Advisory panel
- Clinical Toxicology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code DJK
FDA has cleared device under product code DJK, all in 1978, 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 DJK
Recent clearances under product code DJK
Data sourced from openFDA. This site is unofficial and independent of the FDA.