RAICHEM PHOSPORUS REAGENT

• K Number: K003012
• Device Name: RAICHEM PHOSPORUS REAGENT
• Manufacturer: HEMAGEN DIAGNOSTICS, INC.
• Date Cleared: 2000-10-25 ( 29 days)
• Product Code: CEO
• Regulation Number: 862.1580

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 862.1580 Phosphorus (inorganic) test system.

(a)
Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Summary

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