££......Osmetech ......Smell the Success.....££

I've not been following this board in detail, so I'm not really up to date - though I still own shares, having been in since the days of Aromascan. I apologise therefore to those who already know this. But could someone please update me regarding the FDA approval which is apparently imminent?

I have downloaded a 510[k] notification letter to Osmetech from the FDA dated 20th September 2005
[see

If you click onto "FDA Review" toward the bottom, you'll find a file called k052027[1].pdf which is a facsimile of the Osmetech submission and of the FDA reply letter dated 29th September 2005.

This letter seems to tell Osmetech that the FDA are satisfied with the sumitted device and clears Osmetech to market it, i.e that the "substantial equivalence" of the device has been accepted by the FDA.

My question is "What further approval of this device is awaited?" Or have I got it completely wrong?

regards & Happy New Year
PeterG