FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch— 510(k) K160462
Substantially EquivalentBiofire Diagnostics, LLC
FDA 510(k) clearance K160462 for FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch, Substantially Equivalent on 2016-03-17. 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
- Substantially Equivalent
- Clearance type
- Special
- Location
- Salt Lake City, UT, US
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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.