ALPCO/MERCODIA INSULIN ELISA

• K Number: K963911
• Device Name: ALPCO/MERCODIA INSULIN ELISA
• Manufacturer: AMERICAN LABORATORY PRODUCTS CO., LTD.
• Date Cleared: 1996-11-01 ( 32 days)
• Product Code: CFP
• Regulation Number: 862.1405

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

§ 862.1405 Immunoreactive insulin test system.

(a)
Identification. An immunoreactive insulin test system is a device intended to measure immunoreactive insulin in serum and plasma. Immunoreactive insulin measurements are used in the diagnosis and treatment of various carbohydrate metabolism disorders, including diabetes mellitus, and hypoglycemia.(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 § 862.9.

Summary

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