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510(k) Data Aggregation
K Number
K964192Device Name
ARDENT NON GAMMA-2 70
Manufacturer
Date Cleared
1997-01-06
(81 days)
Product Code
Regulation Number
872.3070Why did this record match?
Applicant Name (Manufacturer) :
ARDENT PRODUCTION DEVELOPMENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K964775Device Name
ARDENT FUTURA NON GAMMA-2
Manufacturer
Date Cleared
1996-12-10
(54 days)
Product Code
Regulation Number
872.3070Why did this record match?
Applicant Name (Manufacturer) :
ARDENT PRODUCTION DEVELOPMENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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