WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER— 510(k) K953116
Substantially EquivalentIntl. Remote Imaging Systems
FDA 510(k) clearance K953116 for WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER, Substantially Equivalent on 1996-05-13. Applicant: Intl. Remote Imaging Systems.
Clearance details
- Applicant
- Intl. Remote Imaging Systems
- Product code
- Code GKZ
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chatsworth, 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.