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510(k) Data Aggregation
K Number
K970124Device Name
LIPASE REAGENT SET (COLIPASE METHOD)Manufacturer
Date Cleared
1997-03-06
(51 days)
Product Code
Regulation Number
862.1465Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
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Product Code :
CET
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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