CZK — Iga, Rhodamine, Antigen, Antiserum, Control Class II
FDA product code CZK covers "Iga, Rhodamine, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5510. 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
- CZK
- Device Class
- Class II
- Regulation Number
- 866.5510
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K833841 | instrumentation laboratory | IL TEST IGG IGA & IGM KITS | January 4, 1984 |