DHF — D/Km-1, Antigen, Antiserum, Control Class I
FDA product code DHF covers "D/Km-1, Antigen, Antiserum, Control", a Class I medical device regulated under 21 CFR 866.5065. 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
- DHF
- Device Class
- Class I
- Regulation Number
- 866.5065
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K940243 | ventana medical systems | VENTANA EMA PRIMARY ANDIBODY | September 7, 1994 |