EasyStat 300— 510(k) K220396

Substantially Equivalent

Medica Corporation

FDA 510(k) clearance K220396 for EasyStat 300, Substantially Equivalent on 2023-09-26. Applicant: Medica Corporation. Device class: 2.

Clearance details

Applicant
Medica Corporation
Product code
Code CEM
Device class
Class 2
Regulation
21 CFR 862.1600
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bedford, MA, US
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