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K Number
K061944
Device Name
POLY-CHEM CREATININE
Manufacturer
POLYMEDCO, INC.
Date Cleared
2006-11-03

(116 days)

Product Code
JFY
Regulation Number
862.1225
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
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

Not Found

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.

§ 862.1225 Creatinine test system.

(a)
Identification. A creatinine test system is a device 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.(b)
Classification. Class II.