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K Number
K982035
Device Name
OLYMPUS CALCIUM ARSENAZO III REAGENT
Manufacturer
OLYMPUS DIAGNOSTICA GMBH
Date Cleared
1998-06-24

(14 days)

Product Code
CJY
Regulation Number
862.1145
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Olympus Calcium Arsenazo Reagent is intended for the quantitative determination of Calcium concentrations in human serum on Olympus clinical chemistry analyzers.

Device Description

Olympus Calcium Arsenazo Reagent

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the Olympus Calcium Arsenazo Reagent. It does not contain information about the acceptance criteria or a study proving the device meets said criteria in the format requested. The document primarily discusses the substantial equivalence of the device to pre-amendment devices and regulatory information.

Therefore, I cannot provide the requested information based on the provided text.

§ 862.1145 Calcium test system.

(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.