FDA.report

510(k) K220328

Device
EasyStat 300
Applicant
Medica Corporation
510(k) number
K220328
Product code
CGA
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-26
Date received
2022-02-04
Regulation
862.1345
Classification name
Glucose Oxidase, Glucose
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Photios Makris
Address
5 Oak Park Dr. Bedford MA US 01730 01730

FDA Registration Numbers

Source Documents

510(k) summary PDF

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