Published in Medical Letter on the CDC and FDA, March 7th, 2004
FDA clearance is required before a company can bring a medical device or product to market. In addition to OnTrak TesTcup II and OnSite CupKit receiving FDA clearance, all of Varian, Inc.'s urine-based rapid drugs-of-abuse testing products have 510(k) status, including the current market-leading OnTrak TesTcup and OnTrak TesTstik product lines.
The OnSite CupKit...
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