FILMARRAY RESPIRATORY PANEL (RP)— 510(k) K123620

Name: FDA 510(k) clearance K123620
Creator: U.S. Food and Drug Administration
Published: 2013-02-11

Substantially Equivalent

Biofire Diagnostics, Inc.

FDA 510(k) clearance K123620 for FILMARRAY RESPIRATORY PANEL (RP), Substantially Equivalent on 2013-02-11. Applicant: Biofire Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Biofire Diagnostics, Inc.
Product code: Code OCC
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2012-11-23
Decision date: 2013-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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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.