Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify the FDA at least 90 days in advance of their intent to market a medical device. Even though instant drug test kits are not classified as medical devices and therefore fall outside the FDA jurisdiction, many manufacturers obtain FDA 510k clearance to insure consumer security. FDA 510k Clearance certifies that the employee drug testing device passes FDA standards.
All our drug testing kits are FDA Cleared unless they say for Forensic Use Only
FDA 510k Clearance documents for the above employee drug screening kits can be downloaded from our website and be found on the corresponding product pages.
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