The AlcoMate Series Breathalyzers are FDA 510(k) Certified

The U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.

Before granting approval to manufacturers to sell their new devices, FDA science experts review the manufacturer’s data from investigational studies to see if

	The product does what it claims to do effectively, and does not present any unreasonable risks to the user
	After reviewing the AlcoMate Series, the FDA has granted marketing clearance for Models AlcoMate and AlcoMate Pro Digital Breathalyzers for use in measuring alcohol intoxication.