DFF — Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control Class II
FDA product code DFF covers "Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5080. Submissions are reviewed by the Immunology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- DFF
- Device Class
- Class II
- Regulation Number
- 866.5080
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K863868 | cooper biomedical | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT | February 13, 1987 |