Tks Trout - Yes it was the 510[k] approval for the Opti device.
But I've searched the FDA web site for Cystic Fibrosis and can find nothing which is apparently relevant to Osmetech. I've quickly gone through part of the OMH website and couldn't see anything about FDA submission there either.
So:
Can you fill in the gaps for me please?
Which company in the OMH group submitted an application to the FDA & when?
What is the name of the device?
I like to follow these through the FDA path - but can't find the correct doorway!!
regds
PG