STA R Max 3, STA Compact Max 3— 510(k) K212183
Substantially EquivalentDiagnostica Stago S.A.S
FDA 510(k) clearance K212183 for STA R Max 3, STA Compact Max 3, Substantially Equivalent on 2023-06-07. Applicant: Diagnostica Stago S.A.S.
Clearance details
- Applicant
- Diagnostica Stago S.A.S
- Product code
- Code JPA
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Asniéres Sur Seine, FR
Adverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
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.