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Tosoh Bioscience, Inc.

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories4
Latest FDA decision2025-10-03
TypeNumberDevice NameCodeDateActions
510(k) K250073 Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01PDJ2025-10-03 View
510(k) K211199 ST AIA-PACK BNP AssayNBC2021-11-08 View
510(k) K200904 Tosoh Automated Glycohemoglobin Analyzer HLC-723G8PDJ2021-08-05 View
PMA P910065 Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancerMTF2019-06-18 View
510(k) K160113 ST AIA-PACK hsE2 Calibrator SetJIT2016-02-17 View
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