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Found 2 results
510(k) Data Aggregation
K Number
K965099Device Name
ACCUMETER H. PYLORI TESTManufacturer
Date Cleared
1997-02-20
(62 days)
Product Code
Regulation Number
866.3110Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
ACCUMETER H. PYLORI TEST
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K960478Device Name
ACCUMETER H. PYLORI TESTManufacturer
Date Cleared
1996-06-27
(146 days)
Product Code
Regulation Number
866.3110Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
ACCUMETER H. PYLORI TEST
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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