FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL— 510(k) K130914

Substantially Equivalent

Biofire Diagnostics, Inc.

FDA 510(k) clearance K130914 for FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL, Substantially Equivalent on 2013-06-21. Applicant: Biofire Diagnostics, Inc..

Clearance details

Applicant: Biofire Diagnostics, Inc.
Product code: Code PEN
Advisory panel: Microbiology
Date received: 2013-04-02
Decision date: 2013-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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Adverse events under product code PEN

product code PEN

Death: 7
Total: 7

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.