HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)

• K Number: K011389
• Device Name: HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)
• Manufacturer: CANTERBURY HEALTH LABORATORIES
• Date Cleared: 2001-06-21 ( 45 days)
• Product Code: JCM
• Regulation Number: 864.7415

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

§ 864.7415 Abnormal hemoglobin assay.

(a)
Identification. An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.(b)
Classification. Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Summary

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