STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER— 510(k) K082248

Substantially Equivalent

Diagnostica Stago, Inc.

FDA 510(k) clearance K082248 for STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER, Substantially Equivalent on 2008-12-12. Applicant: Diagnostica Stago, Inc..

Clearance details

Applicant: Diagnostica Stago, Inc.
Product code: Code JPA
Advisory panel: Hematology
Date received: 2008-08-08
Decision date: 2008-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parisppany, NJ, US

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.