LogoFDA 510(k) Search
K Number
K012649
Device Name
RAICHEM BUN RATE REAGENT
Manufacturer
HEMAGEN DIAGNOSTICS, INC.
Date Cleared
2001-10-15

(63 days)

Product Code
CDQ
Regulation Number
862.1770
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This reagent is for the quantitative in vitro enzymatic determination of urea nitrogen (BUN) in serum or plasma. For in vitro diagnostic use only.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter for a medical device (Raichem® BUN Rate Reagent) and its indications for use. It does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a performance study. These details are typically found in the 510(k) submission summary or the full submission, not in the clearance letter itself.

Therefore, I cannot provide the requested table and study details based on the given input. The document focuses on regulatory approval rather than the technical performance evaluation study.

§ 862.1770 Urea nitrogen test system.

(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.