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510(k) K240041

IVD CAPSULE PSP; abioSCOPE by Abionic SA — Product Code SCX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 25, 2024
Date Received: January 5, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

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

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