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510(k) Data Aggregation
K Number
K002638Device Name
FUTURE DIAGNOSTICS B.V. STAT-ACTH KITManufacturer
Date Cleared
2001-01-17
(146 days)
Product Code
Regulation Number
862.1025Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
FUTURE DIAGNOSTICS B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K000471Manufacturer
Date Cleared
2000-04-11
(57 days)
Product Code
Regulation Number
862.1545Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
FUTURE DIAGNOSTICS B.V.
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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