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510(k) K230944

MeMed BV by MeMed Diagnostics, Ltd. — Product Code QPS

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 30, 2023
Date Received: April 4, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Immunoassay For Host Biomarkers Of Infection
Device Class: Class II
Regulation Number: 866.3215
Review Panel: MI
Submission Type

A semi-quantitative immunoassay that quantifies the relative levels of host response proteins isolated from serum or similar specimens.