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510(k) Data Aggregation
K Number
K002128Device Name
ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100Manufacturer
Date Cleared
2000-12-05
(144 days)
Product Code
Regulation Number
862.1260Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
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Product Code :
NDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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