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