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Diazyme Laboratories

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories8
Latest FDA decision2018-01-11
TypeNumberDevice NameCodeDateActions
510(k) K172992 Diazyme EZ Vitamin D AssayMRG2018-01-11 View
510(k) K163418 Diazyme DZ-Lite Total beta-hCG Test SystemDHA2017-08-18 View
510(k) K162297 Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control SetPTF2017-04-18 View
510(k) K160762 Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control SetLCP2016-11-21 View
510(k) K153394 Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain CalibratorDFH2016-11-18 View
510(k) K161646 Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control SetCGN2016-11-04 View
510(k) K161721 Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetCDD2016-09-20 View
510(k) K143470 Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control SetGIS2016-01-31 View
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