STA COMPACT MAX— 510(k) K130090

Substantially Equivalent

Diagnostica Stago, Incorporated

FDA 510(k) clearance K130090 for STA COMPACT MAX, Substantially Equivalent on 2013-02-12. Applicant: Diagnostica Stago, Incorporated.

Clearance details

Applicant: Diagnostica Stago, Incorporated
Product code: Code JPA
Advisory panel: Hematology
Date received: 2013-01-14
Decision date: 2013-02-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Rome, IT

Download summary PDF View on FDA.gov ↗

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.