FDAnews Device Daily Bulletin

MEDTOX SCIENTIFIC RECEIVES FDA 510(K) CLEARANCE FOR ITS NEW SURE-SCREEN DEVICE

Nov. 4, 2005
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MEDTOX Scientific recently announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Sure-Screen drugs-of-abuse point-of-collection test (POCT) device. Sure-Screen is a POCT device intended to provide significantly lower detection levels for eight commonly abused drugs. Current tests provide detection levels that have been established by the Substance Abuse and Mental Health Services Administration (SAMHSA), a Federal agency that regulates certain workplace drug testing required under Federal law.

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