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Found 2 results
510(k) Data Aggregation
K Number
K965047Device Name
MINK LUNG CELL CULTUREManufacturer
Date Cleared
1997-02-04
(48 days)
Product Code
Regulation Number
864.2280Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
NEOGENEX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K960909Device Name
H292 CELL CULTUREManufacturer
Date Cleared
1996-05-30
(86 days)
Product Code
Regulation Number
864.2280Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
NEOGENEX
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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