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FDA 510(k) K152579, FilmArray Respiratory Panel EZ (RP EZ), by Biofire Diagnostics, LLC

FDA 510(k) K152579, FilmArray Respiratory Panel EZ (RP EZ), by Biofire Diagnostics, LLC

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510(K) Number: K152579
Device Name: FilmArray Respiratory Panel EZ (RP EZ)
Manufacturer: Biofire Diagnostics, LLC
Device Classification Name: respiratory virus panel nucleic acid assay system
Regulation Number: 866.3980
Classification Product Code: OCC
Date Received: 09/10/2015
Decision Date: 10/03/2016
Regulation Medical Specialty: Microbiology
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