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Meridian Bioscience, Inc.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories7
Latest FDA decision2025-03-20
TypeNumberDevice NameCodeDateActions
510(k) K243922 RevogeneOOI2025-03-20 View
510(k) K230901 Premier HpSA Flex (619096)LYR2023-07-03 View
510(k) K222829 Curian® Shiga ToxinGMZ2023-04-17 View
510(k) K222779 RevogeneOOI2023-01-26 View
510(k) K220480 RevogeneOOI2022-07-11 View
510(k) K210976 Curian CampyLQP2021-12-23 View
PMA P100025 Test, urea adult and pediatric (breath),OZA2020-05-26 View
510(k) K192817 Curian HpSA, Curian AnalyzerLYR2020-03-13 View
510(k) K182559 PREMIER Platinum HpSA PLUSLYR2018-11-05 View
510(k) K163273 TRU LegionellaMJH2017-02-21 View
510(k) K160829 illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10OZX2016-06-13 View
510(k) K153661 ImmunoCard STAT! HpSALYR2016-03-14 View
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