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Found 2 results
510(k) Data Aggregation
K Number
K001352Manufacturer
Date Cleared
2001-04-09
(346 days)
Product Code
Regulation Number
866.5820Type
TraditionalPanel
ImmunologyReference & Predicate Devices
N/A
Why did this record match?
Product Code :
DHC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K001398Manufacturer
Date Cleared
2001-03-30
(331 days)
Product Code
Regulation Number
866.5820Type
TraditionalPanel
ImmunologyReference & Predicate Devices
N/A
Why did this record match?
Product Code :
DHC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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