DDE — Carbonic Anhydrase C, Antigen, Antiserum, Control Class I
FDA product code DDE covers "Carbonic Anhydrase C, Antigen, Antiserum, Control", a Class I medical device regulated under 21 CFR 866.5200. Submissions are reviewed by the Immunology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DDE
- Device Class
- Class I
- Regulation Number
- 866.5200
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Immunology
- Implant
- No