CBC-CAL PLUS HEMATOLOGY CALIBRATOR

• K Number: K955925
• Device Name: CBC-CAL PLUS HEMATOLOGY CALIBRATOR
• Manufacturer: R & D SYSTEMS, INC.
• Date Cleared: 1996-02-29 ( 69 days)
• Product Code: KRX , KRY , KRZ , KSA
• Regulation Number: 864.8150
• Type: Traditional
• Panel: HE
• 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

§ 864.8150 Calibrator for cell indices.

(a)
Identification. A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.