FilmArray Pneumonia Panel— 510(k) K180966
Substantially EquivalentBiofire Diagnostics, LLC
FDA 510(k) clearance K180966 for FilmArray Pneumonia Panel, Substantially Equivalent on 2018-11-09. Applicant: Biofire Diagnostics, LLC. Device class: 2.
Clearance details
- Applicant
- Biofire Diagnostics, LLC
- Product code
- Code QDP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3985
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code QDP
view allMore clearances from Biofire Diagnostics, LLC
view all- K243544 — BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
- K243885 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
- K243759 — BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
- K242367 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
- K241194 — BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
Recalls naming K180966
K-number listed on FDA's recall record- Z-0994-2024 — FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
- Z-2440-2023 — FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
- Z-2039-2021 — FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)
- Z-1944-2021 — FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180966.
Data sourced from openFDA. This site is unofficial and independent of the FDA.