2024-20895. Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test System

Table 1—Clozapine Test System Risks and Mitigation Measures

Identified risks to health	Mitigation measures
Incorrect test results	Certain design verification and validation activities and Certain labeling information.
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Incorrect interpretation of test results	Certain design verification and validation activities and Certain labeling information.