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Bio-Rad Laboratories, Inc.

FDA 510(k) & PMA Approved Devices — 3 products

Total Devices3
Categories3
Latest FDA decision2019-02-13
TypeNumberDevice NameCodeDateActions
510(k) K181661 QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemOYX2019-02-13 View
510(k) K171664 Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareGKA2017-09-13 View
510(k) K161687 D-10 Hemoglobin A1c ProgramPDJ2016-10-14 View