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510(k) Data Aggregation
K Number
K003318Manufacturer
Date Cleared
2001-05-22
(210 days)
Product Code
Regulation Number
878.4810Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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