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Bio-Rad Laboratories

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories7
Latest FDA decision2025-04-18
TypeNumberDevice NameCodeDateActions
PMA P050048 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-04-18 View
510(k) K183446 BioPlex 2200 Lyme TotalLSR2019-03-12 View
510(k) K180577 BioPlex 2200 25-OH Vitamin D KitMRG2018-06-22 View
510(k) K170509 BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control SetPUQ2017-05-19 View
510(k) K170413 BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control SetLIP2017-05-11 View
510(k) K163015 Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakJJY2017-01-10 View
510(k) K152679 Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPakPMN2016-05-10 View
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