FDA.reportPublic FDA data

510(k) K220396

Device
EasyStat 300
Applicant
Medica Corporation
510(k) number
K220396
Product code
CEM
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-26
Date received
2022-02-11
Regulation
862.1600
Classification name
Electrode, Ion Specific, Potassium
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

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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K083680VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258Ortho-Clinical Diagnostics, Inc.2009-02-27