KSZ — System, Test, Automated Blood Grouping And Antibody Class II
FDA product code KSZ covers "System, Test, Automated Blood Grouping And Antibody", a Class II medical device regulated under 21 CFR 864.9175. Submissions are reviewed by the Hematology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KSZ
- Device Class
- Class II
- Regulation Number
- 864.9175
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K810899 | technicon instruments | TECHNICON AUTOGROUPER 16-C SYSTEM | May 5, 1981 |
| K790282 | nordisk infuser system | ELDONCARD | May 4, 1979 |
| K771098 | technicon instruments | BLOOD GROUPING SYS., BG-9 | August 4, 1977 |
| K770185 | bd becton dickinson vacutainer systems preanalytic | RH CONTROL DILUENT | March 14, 1977 |