Product code KSZ
- Device name
- System, Test, Automated Blood Grouping And Antibody
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.9175
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
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