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510(k) Data Aggregation
K Number
K994045Manufacturer
Date Cleared
1999-12-21
(22 days)
Product Code
Regulation Number
864.7470Type
SpecialPanel
HematologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
In vitro diagnostic use to establish reference points for glycated hemoglobin test methods
Device Description
Not Found
AI/ML Overview
The provided text is a 510(k) clearance letter from the FDA for "Primus Liquid Calibrators for GHb/A1c Level 1 and Level 2." While it confirms the device is substantially equivalent to a predicate, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information from the given input. The document is solely an FDA clearance letter and does not detail the technical study data or acceptance criteria used for approval.
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