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510(k) K251157

Core Metabolic by Truvian Health — Product Code CIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2026
Date Received
April 15, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Green Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type

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