seems like you guys in the states are drowning in red tape.
the day after my operation the nurses came to my bed and said "we strongly recommend you get a roache coaguchek, order it on this 0800 number today and we will teach you how to use it tommorrow" qed.
so i phoned roache and it arrived in my room by 10.00 am the next morning and the nurse showed me how to use it in the afternoon.
the only approval required was my own; and that is exactly how it should be!
and i have never heard doctors, nurses etc here question its accuracy etc, everyone seems to think its a bloody marvel. i 100% trust my coaguchek and never go near a lab.
i am not trying to be a comedian, but have you tried phoning roache direct and buying one over the phone with your credit card? and if that fails, why not just import one yourself?