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Sun Biomedical Provides Update on OraLine FDA 510
Tuesday January 22, 2008, 11:07 am

Original Announcement: Update on OraLine FDA 510(k) submission

Sun Biomedical advised that it has received formal advice from the US Food and Drug Administration (FDA) that the Company's 510(k) submission for saliva drug testing device OraLine has not met FDA requirements for 510(k) clearance. The FDA's notification cites that the performance data provided in the submission did not demonstrate the device to be as effective as legally marketed devices. The Company notes that at present there is no legally marketed point of care saliva device.

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