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Success Stories |
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7500 Fast Dx Clearance"For exceptional performance and dedication in addressing complex regulatory and scientific issues in the clearance of a CDC test to diagnose human influenza infections." 2009 FDA Honor Awards Commissioner's Special...
GeneChip 3000Dx ClearanceWhen FDA cleared our de novo 501(k) for the GeneChip 3000DX, it was the first microarray to be cleared for diagnostic testing. It was cleared in conjunction with Roche's AmpliChip...
Not-So-Good NewsWe won't name names on this one, but some of our greatest successes have been for companies who got less than they wanted. We consider our work a success because... |
Featured ItemsA Better 510k Webinar So, let's be honest: yesterday's webinar on the proposed 510k changes was a disappointment. I... Back to Basics We've been doing a somewhat-regular blog for almost two years now. As we've built readership,... Putting the "Lab" Back in LDTs You have to feel for clinical labs after last week. They do such important work... |
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