FilmArray Pneumonia Panel— 510(k) K212727
Substantially EquivalentBiofire Diagnostics, LLC
FDA 510(k) clearance K212727 for FilmArray Pneumonia Panel, Substantially Equivalent on 2021-09-22. 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
- Special
- Location
- Salt Lake City, UT, US
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Recalls naming K212727
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 K212727.
Data sourced from openFDA. This site is unofficial and independent of the FDA.