FilmArray Respiratory Panel EZ (RP EZ)— 510(k) K152579

Name: FDA 510(k) clearance K152579
Creator: U.S. Food and Drug Administration
Published: 2016-10-03

Substantially Equivalent

Biofire Diagnostics, LLC

FDA 510(k) clearance K152579 for FilmArray Respiratory Panel EZ (RP EZ), Substantially Equivalent on 2016-10-03. Applicant: Biofire Diagnostics, LLC. Device class: 2.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code OCC
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2015-09-10
Decision date: 2016-10-03
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OCC

view all

K262747 — ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.02026-08-31
K254139 — BioCode® Respiratory Pathogen Panel (RPP)2026-05-01
K242613 — NxTAG® Respiratory Pathogen Panel2024-10-02
K232775 — ID NOW Influenza A & B 22023-10-10
K231017 — Panther Fusion AdV/hMPV/RV Assay2023-05-05

More clearances from Biofire Diagnostics, LLC

view all

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.