fda 510k approval, page-13

Brown,

Fair enough question - but it's not really much of an issue.

The FDA does not anticipate any real difficulties as the gave SBN permission to recommence marketing the product - so unlike Oraline - no impact on current sales pending clearance. Here's the relevant part of the 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."

SBN is applying all available resources to moving through the Oraline clearance due to the maarket potential AND because it is off market until clearance is obtained.