THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS

• K Number: K961814
• Device Name: THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS
• Manufacturer: CARDIOVASCULAR DIAGNOSTICS, INC.
• Date Cleared: 1996-08-13 ( 95 days)
• Product Code: GIZ GGC GGN GJS
• Regulation Number: 864.5425

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

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies 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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