FilmArray Meningitis/Encephalitis(ME) Panel— 510(k) DEN150013

Unknown

Biofire Diagnostics, LLC

FDA 510(k) clearance DEN150013 for FilmArray Meningitis/Encephalitis(ME) Panel, Unknown on 2015-10-08. Applicant: Biofire Diagnostics, LLC.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code PLO
Advisory panel: Microbiology
Date received: 2015-04-09
Decision date: 2015-10-08
Decision: Unknown
Clearance type: Direct
Location: Salt Lake City, UT, US

View on FDA.gov ↗

Adverse events under product code PLO

product code PLO

Death: 5
Total: 5

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.