JPJ — Red-Cell Indices, Calculated Class II
FDA product code JPJ covers "Red-Cell Indices, Calculated", a Class II medical device regulated under 21 CFR 864.5300. Submissions are reviewed by the Hematology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JPJ
- Device Class
- Class II
- Regulation Number
- 864.5300
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No