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510(k) Data Aggregation
K Number
K061944Device Name
POLY-CHEM CREATININEManufacturer
Date Cleared
2006-11-03
(116 days)
Product Code
Regulation Number
862.1225Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
Why did this record match?
Device Name :
POLY-CHEM CREATININE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Poly-Chem Creatinine test is intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Device Description
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AI/ML Overview
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a creatinine test system. It does not contain information about the acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device. Therefore, I cannot fulfill your request based on the given input.
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