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510(k) Data Aggregation
K Number
K010877Device Name
CHEMWELL, MODEL 2900Manufacturer
Date Cleared
2001-05-23
(61 days)
Regulation Number
862.1035Type
AbbreviatedPanel
Clinical ChemistryReference & Predicate Devices
N/A
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Device Name :
CHEMWELL, MODEL 2900
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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