Osmetech Receives 510 (k) Clearance for CF Assay

Osmetech Molecular Diagnostics has received 510 (k) clearance from the US Food and Drug Administration for a cystic fibrosis carrier detection assay that runs on its eSensor Detection System, according to a company official.

The approval appears to make Osmetech the third company to bring an array-based IVD through the regulatory process (see BAN 1/3/2006).

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