STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS

• K Number: K960120
• Device Name: STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS
• Manufacturer: NOVA BIOMEDICAL CORP.
• Date Cleared: 1996-03-11 ( 60 days)
• Product Code: JFP , CDS , CFA , CHL , JJS
• Regulation Number: 862.1145
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 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.