510(k) BK180275
- Device
- Automated Blood Grouping And Antibody Test Systems
- Applicant
- Bio-Rad Medical Diagnostics GmbH
- 510(k) number
- BK180275
- Product code
- KSZ
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2019-03-21
- Date received
- 2018-12-12
- Regulation
- 864.9175
- Classification name
- System, Test, Automated Blood Grouping And Antibody
- Clearance type
- 510(k) Special
- Third party reviewed
- No
Other 510(k) Records For Product Code KSZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K810899 | TECHNICON AUTOGROUPER 16-C SYSTEM | Technicon Instruments Corp. | 1981-05-05 |
| K790282 | ELDONCARD | Nordisk Infuser System | 1979-05-04 |
| K771098 | BLOOD GROUPING SYS., BG-9 | Technicon Instruments Corp. | 1977-08-04 |
| K770185 | RH CONTROL DILUENT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-03-14 |