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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 862 - Clinical Chemistry and Clinical Toxicology Devices |
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Subpart D - Clinical Toxicology Test Systems |
§ 862.3050 - Breath-alcohol test system.
Latest version.
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§ 862.3050 Breath-alcohol test system.
(a) Identification. A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
(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 § 862.9.
[52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019]