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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 4 of 4 Results
510(K) Number: K180966
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FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144 2 06/24/2021 FEI # 3002773840
BioFire Diagnostics, LLC
FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (3... 2 07/08/2021 FEI # 3002773840
BioFire Diagnostics, LLC
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only 2 08/21/2023 FEI # 3002773840
BioFire Diagnostics, LLC
FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit) 2 02/06/2024 FEI # 3002773840
BioFire Diagnostics, LLC
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