QUALITROL IGAME CONTROLS, LEVELS 1 AND 2

• K Number: K961544
• Device Name: QUALITROL IGAME CONTROLS, LEVELS 1 AND 2
• Manufacturer: CONSOLIDATED TECHNOLOGIES, INC.
• Date Cleared: 1996-09-24 ( 155 days)
• Product Code: DGR
• Regulation Number: 866.5700

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

§ 866.5700 Whole human plasma or serum immunological test system.

(a)
Identification. A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by immunochemical techniques the proteins in plasma or serum. Measurements of proteins in plasma or serum aid in the diagnosis of any disease concerned with abnormal levels of plasma or serum proteins, e.g., agammaglobulinemia, allergies, multiple myeloma, rheumatoid vasculitis, or hereditary angioneurotic edema.(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 § 866.9.

Summary

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