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510(k) Data Aggregation
K Number
K073431Manufacturer
Date Cleared
2008-01-14
(39 days)
Product Code
Regulation Number
864.6550Type
SpecialPanel
HematologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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