DCJ — Beta-Globulin, Antigen, Antiserum, Control Class I
FDA product code DCJ covers "Beta-Globulin, Antigen, Antiserum, Control", a Class I medical device regulated under 21 CFR 866.5160. 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
- DCJ
- Device Class
- Class I
- Regulation Number
- 866.5160
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K891093 | e.i. dupont de nemours and co | ACA (R) DIGITOXIN CALIBRATOR | April 26, 1989 |