FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch— 510(k) K160462

Substantially Equivalent

Biofire Diagnostics, LLC

FDA 510(k) clearance K160462 for FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch, Substantially Equivalent on 2016-03-17. Applicant: Biofire Diagnostics, LLC.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code PLO
Advisory panel: Microbiology
Date received: 2016-02-19
Decision date: 2016-03-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

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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.