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510(k) Data Aggregation
K Number
K001177Manufacturer
Date Cleared
2000-11-13
(216 days)
Product Code
Regulation Number
866.3110Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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