Home / Companies / Diazyme Laboratories

Diazyme Laboratories

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
50
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253358Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain AssayDecember 19, 2025
K243462Diazyme Colorimetric Lithium AssayAugust 1, 2025
K211648Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssaySeptember 8, 2022
K220001Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayAugust 4, 2022
K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence ImmunoassDecember 13, 2021
K203136Diazyme PLAC® Test for Lp-PLA2 ActivityAugust 6, 2021
K180209Diazyme 1,5-AG AssayOctober 4, 2018
K181438Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain AssayJune 26, 2018
K180074Diazyme Lipoprotein (a) AssayMarch 22, 2018
K172992Diazyme EZ Vitamin D AssayJanuary 11, 2018
K163418Diazyme DZ-Lite Total beta-hCG Test SystemAugust 18, 2017
K162297Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme ProcalcitoninApril 18, 2017
K160762Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, DNovember 21, 2016
K153394Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme HumNovember 18, 2016
K161646Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control SetNovember 4, 2016
K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetSeptember 20, 2016
K143470Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control SetJanuary 31, 2016
K133803DIAZYME GLYCATED SERUM PROTEIN POC TEST KITAugust 6, 2014
K133083DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SETJune 24, 2014
K133410DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SETMarch 14, 2014