Medica Corporation
Medica Corporation holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2024, with 4 FDA device recalls on record.
Top product codes for Medica Corporation
FDA recalls by Medica Corporation
- Z-1370-2026 — Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
- Z-1294-2019 — Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wash solution in the wedge is used to prevent interference between certain tests.
- Z-1149-2018 — Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution is used prior to a lipase (LIP) assay if an interferant assay (TRIG)is part of the work list. The major interferant for Lipase is the Triglycerides (TRIG) assay since one of the reagents contains lipase as an active ingredient.
- Z-1267-2018 — EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Medica Corporation
- K220328 — EasyStat 300
- K220396 — EasyStat 300
- K211559 — EasyStat 300
- K152327 — EasyLyte Na/K/Cl/Ca Analyzer
- K130080 — EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL
- K123586 — EASYRA CREATININE REAGENT
- K111036 — EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.