STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER— 510(k) K093001

Name: FDA 510(k) clearance K093001
Creator: U.S. Food and Drug Administration
Published: 2009-12-18

Substantially Equivalent

Diagnostica Stago, Incorporated

FDA 510(k) clearance K093001 for STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER, Substantially Equivalent on 2009-12-18. Applicant: Diagnostica Stago, Incorporated. Device class: 2.

Clearance details

Applicant: Diagnostica Stago, Incorporated
Product code: Code JPA
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 2009-09-28
Decision date: 2009-12-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Parisppany, NJ, US

Download summary PDF View on FDA.gov ↗

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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.