EasyStat 300— 510(k) K220328

Clearance details

Applicant

Medica Corporation

Product code

Code CGA

Device class

Class 2

Regulation

21 CFR 862.1345

Advisory panel

Clinical Chemistry

Date received

2022-02-04

Decision date

2024-07-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bedford, MA, US

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• K130080 — EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL2014-05-13
• K123586 — EASYRA CREATININE REAGENT2013-05-15

Death

2

Malfunction

1,816

Total

1,818

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →