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510(k) Data Aggregation
K Number
DEN240035Device Name
ConcizuTrace ELISA
Manufacturer
Randox Laboratories Ltd
Date Cleared
2025-05-22
(325 days)
Product Code
SES
Regulation Number
864.7298Why did this record match?
Product Code :
SES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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