FilmArray Respiratory Panel (RP) for use with FilmArray Torch— 510(k) K160068
Substantially EquivalentBiofire Diagnostics, LLC
FDA 510(k) clearance K160068 for FilmArray Respiratory Panel (RP) for use with FilmArray Torch, Substantially Equivalent on 2016-02-08. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Salt Lake City, UT, US
Recent devices under product code OCC
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
Adverse events under product code OCC
product code OCC- Death
- 3
- Malfunction
- 706
- Total
- 709
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K160068
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160068.
Data sourced from openFDA. This site is unofficial and independent of the FDA.