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510(k) Data Aggregation
K Number
K980573Device Name
SENSOREX BLOOD GLUCOSE MONITORING SYSTEMManufacturer
Date Cleared
1998-07-30
(163 days)
Product Code
Regulation Number
862.1345Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SENSOREX BLOOD GLUCOSE MONITORING SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The quantitative determination of glucose in whole blood.
Device Description
Blood Glucose Monitoring System ( Meter, Test Strips, Control Solutions )
AI/ML Overview
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a blood glucose monitoring system, which confirms the device's substantial equivalence to a predicate device. It does not include details about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.
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