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510(k) Data Aggregation
K Number
DEN040002Manufacturer
Date Cleared
2004-08-24
(53 days)
Product Code
Regulation Number
862.1055Type
Post-NSEPanel
Clinical ChemistryReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
PERKINELMER LIFE SCIENCES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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