What are the ramifications if a breath alcohol tester has not obtained FDA 510(K) pre-marketing notification?
The Food and Drug Administration (FDA) classifies all breath alcohol testing devices as medical devices requiring pre-marketing clearance through the submission of a 510(k) Application. The 510(k) enables the FDA to determine if the device is safe and effective for over-the-counter use. Thus, before any breath alcohol tester can be commercially distributed and sold in the United States for personal use, FDA 510(k) pre-marketing notification clearance is necessary. The entire AlcoHAWK® series Breathalyzer is 510(k) pre-marketing notification cleared by the FDA.
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