Melbourne, Oct 24, 2007 AEST (ABN Newswire) - Harrington Group (ASX: HGR) advises that having completed the necessary studies the Company's subsidiary Sun Biomedical Laboratories (SBL) has filed for US Food and Drug Administration (FDA) 510(k) clearance for the Company's saliva illicit drug screening device OraLine.
The Company will resume selling Oraline into the US workplace testing market once 510(k) clearance has been received from the FDA. The product is presently marketing for forensic use.
The Company is the first organisation to file for a multi drug 510(k) clearance on a saliva illicit drug testing device and is optimistic subject to FDA review that clearance could be achieved within the first quarter of calendar year 2008. With no saliva tests having attained 510(k) clearance, the Company views the matter of compliance with FDA guidelines as a strategic imperative that will provide a significant competitive advantage in the U.S. market.
All available resources are focused on delivering 510(k) clearance in the shortest practical timeframe.
Contact
Brian Andrews
Managing Director
Tel: +61-3-8610-6371
www.hgrltd.com
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