HGR unknown

in the earlier 1August announcement, the company said they would...

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    in the earlier 1August announcement, the company said they would be making application to the FDA in respect of the OralLine IV, oral fluid (saliva) screening device, by the end of August. Well tomorrow is the end of August so we could have an announcement!

    "The Company 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 urine illicit drug screening devices. Based on FDA
    advice, SBL will recommence marketing of the Company urine illicit drug screening devices
    for workplace testing in the USA effective immediately.
    The Company delayed the urine filing to enable necessary resources to be deployed to
    accelerate the important 510(k) clearance submission for OraLine IV, the Company’s oralfluid
    screening device. The Company’s objective is to be the first manufacturer to realise
    510(k) clearance for a saliva illicit drug test for in workplace testing in the U.S. With the
    accelerated 510(k) clearance studies, the Company now anticipates filing by end of August
    2007.

    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."
 
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Currently unlisted public company.

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