Product code DDE— Immunology
COAT-A-COUNT MORPHINE KIT & COMPONENTS
- Classification name
- Carbonic Anhydrase C, Antigen, Antiserum, Control
- Device class
- Class 1
- Regulation
- 21 CFR 866.5200
- Advisory panel
- Immunology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code DDE
FDA has cleared devices under product code DDE between 1982 and 1990, 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
- 1990
- 1983
- 1982
Top applicants under product code DDE
Recent clearances under product code DDE
Data sourced from openFDA. This site is unofficial and independent of the FDA.