FilmArray Meningitis/Encephalitis(ME) Panel— 510(k) DEN150013
UnknownBiofire Diagnostics, LLC
FDA 510(k) clearance DEN150013 for FilmArray Meningitis/Encephalitis(ME) Panel, Unknown on 2015-10-08. Applicant: Biofire Diagnostics, LLC. Device class: 2.
Clearance details
- Applicant
- Biofire Diagnostics, LLC
- Product code
- Code PLO
- Device class
- Class 2
- Regulation
- 21 CFR 866.3970
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Salt Lake City, UT, US
Recent devices under product code PLO
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view all- K243544 — BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
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- 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 PLO
product code PLO- Death
- 5
- Total
- 5
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.