SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER— 510(k) K911626
Substantially EquivalentSerono Baker Diagnostics System
FDA 510(k) clearance K911626 for SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER, Substantially Equivalent on 1991-09-13. Applicant: Serono Baker Diagnostics System.
Clearance details
- Applicant
- Serono Baker Diagnostics System
- Product code
- Code GKZ
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allentown, PA, US
Adverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.