FilmArray 2.0 System— 510(k) K143178

Substantially Equivalent

Biofire Diagnostics, LLC

FDA 510(k) clearance K143178 for FilmArray 2.0 System, Substantially Equivalent on 2015-01-30. Applicant: Biofire Diagnostics, LLC. Device class: 2.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code NSU
Device class: Class 2
Regulation: 21 CFR 862.2570
Advisory panel: Clinical Chemistry
Date received: 2014-11-04
Decision date: 2015-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K143178

K-number listed on FDA's recall record

Z-3122-2024 — FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-WClass II·Ongoing·BioFire Diagnostics, LLC·20240807

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143178.

Data sourced from openFDA. This site is unofficial and independent of the FDA.