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510(k) Data Aggregation
K Number
K010315Device Name
ISCREEN VISION SCREENER
Manufacturer
Date Cleared
2001-06-01
(119 days)
Product Code
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
ISCREEN, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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