KSZ · System, Test, Automated Blood Grouping And Antibody
Hematology · 21 CFR 864.9175 · Class 2
Overview
| Product Code | KSZ |
|---|---|
| Device Name | System, Test, Automated Blood Grouping And Antibody |
| Regulation | 21 CFR 864.9175 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K810899 | TECHNICON AUTOGROUPER 16-C SYSTEM | Technicon Instruments Corp. | May 5, 1981 | SESE |
| K790282 | ELDONCARD | Nordisk Infuser System | May 4, 1979 | SESE |
| K771098 | BLOOD GROUPING SYS., BG-9 | Technicon Instruments Corp. | Aug 4, 1977 | SESE |
| K770185 | RH CONTROL DILUENT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Mar 14, 1977 | SESE |
Top Applicants
- Technicon Instruments Corp. — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Nordisk Infuser System — 1 clearance
