JBB — Solubility, Hemoglobin, Abnormal Class II
FDA product code JBB covers "Solubility, Hemoglobin, Abnormal", a Class II medical device regulated under 21 CFR 864.7825. Submissions are reviewed by the Hematology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JBB
- Device Class
- Class II
- Regulation Number
- 864.7825
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No