ABX PENTRA 60C+ HEMATOLOGY ANALYZER— 510(k) K003677
Substantially EquivalentAbx Diagnostics
FDA 510(k) clearance K003677 for ABX PENTRA 60C+ HEMATOLOGY ANALYZER, Substantially Equivalent on 2000-12-26. Applicant: Abx Diagnostics.
Clearance details
- Applicant
- Abx Diagnostics
- Product code
- Code GKZ
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, 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.