STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER— 510(k) K082675

Substantially Equivalent

Diagnostica Stago, Inc.

FDA 510(k) clearance K082675 for STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER, Substantially Equivalent on 2008-10-10. Applicant: Diagnostica Stago, Inc..

Clearance details

Applicant: Diagnostica Stago, Inc.
Product code: Code JPA
Advisory panel: Hematology
Date received: 2008-09-15
Decision date: 2008-10-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Parisppany, NJ, US

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Adverse events under product code JPA

product code JPA

Death: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.