KSZ
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- System, Test, Automated Blood Grouping And Antibody
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9175
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 2021: 76 · 2022: 78 · 2023: 151 · 2024: 66 · 2025: 66 · 2026: 28
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TECHNICON AUTOGROUPER 16-C SYSTEM (K810899) | Technicon Instruments Corp. | 1981-05-05 |
| ELDONCARD (K790282) | Nordisk Infuser System | 1979-05-04 |
| BLOOD GROUPING SYS., BG-9 (K771098) | Technicon Instruments Corp. | 1977-08-04 |
| RH CONTROL DILUENT (K770185) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-03-14 |
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Every clearance here is in the API, with alerts when new ones post.