JBY — Aggregometer, Platelet, Photo-Optical Scanning Class II
FDA product code JBY covers "Aggregometer, Platelet, Photo-Optical Scanning", a Class II medical device regulated under 21 CFR 864.6675. 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
- JBY
- Device Class
- Class II
- Regulation Number
- 864.6675
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No