JBZ — Study, Platelet Adhesive Class II
FDA product code JBZ covers "Study, Platelet Adhesive", a Class II medical device regulated under 21 CFR 864.6650. 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
- JBZ
- Device Class
- Class II
- Regulation Number
- 864.6650
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K800037 | hemometrix | PLATELET RETENTION (ADHESION) COLUMNS | February 5, 1980 |
| K771678 | bay area hema. onco. clinic. and res. l | THROMBO-SCREEN PLATELET ADHESION | November 22, 1977 |
| K771523 | bd becton dickinson vacutainer systems preanalytic | LATELET RETENTION COLUMN | November 22, 1977 |