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510(k) Data Aggregation
K Number
K251545Manufacturer
Date Cleared
2025-09-04
(107 days)
Product Code
Regulation Number
878.4810Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
Micowey Medical Equipment (Guangxi) Co., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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