Product code KSZ— Hematology
BLOOD GROUPING SYS., BG-9
- Classification name
- System, Test, Automated Blood Grouping And Antibody
- Device class
- Class 2
- Regulation
- 21 CFR 864.9175
- Advisory panel
- Hematology
- Total cleared
- 4
- First cleared
- Most recent
Market context for product code KSZ
FDA has cleared devices under product code KSZ between 1977 and 1981, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1981
- 1979
- 1977
Top applicants under product code KSZ
Adverse events under product code KSZ
product code KSZ- Malfunction
- 517
- Total
- 517
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code KSZ
Data sourced from openFDA. This site is unofficial and independent of the FDA.