MODIFICATION TO PROFLU+ ASSAY— 510(k) K081030

Substantially Equivalent

Prodesse, Inc.

FDA 510(k) clearance K081030 for MODIFICATION TO PROFLU+ ASSAY, Substantially Equivalent on 2008-05-02. Applicant: Prodesse, Inc..

Clearance details

Applicant: Prodesse, Inc.
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2008-04-11
Decision date: 2008-05-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Waukesha, WI, US

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Adverse events under product code OCC

product code OCC

Death: 3
Malfunction: 706
Total: 709

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.