Medica Corporation

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
7
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1370-2026Class IIMedica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.December 31, 2025
Z-1294-2019Class IIMedica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REFebruary 6, 2019
Z-1149-2018Class IIWash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution November 21, 2017
Z-1267-2018Class IIEasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of April 11, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K220328EasyStat 300July 26, 2024
K220396EasyStat 300September 26, 2023
K211559EasyStat 300January 27, 2023
K152327EasyLyte Na/K/Cl/Ca AnalyzerDecember 1, 2016
K130080EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MAMay 13, 2014
K123586EASYRA CREATININE REAGENTMay 15, 2013
K111036EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENTJuly 12, 2011