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Statistical support (some collaborative with Bright
and Associates) has been provided to ten corporations from various
US states and abroad for PMA and 510k submissions. Their products were
devices of a number of types, and clinical chemistry assays.
These clients include:
- Aksys Inc.
FDA clearance for the PHD home dialysis system
- Cylex Corporation
Approval of the Cylex immune cell function assay
- DiaSorin
PMA and 510k clearances of a number of clinical assays and diagnostics
- Gambro AB
Statistical aspects of several 510k approvals and post-market studies
of dialysis devices.
- Mentor Corporation
Submission of a brachytherapy device
- Roche Molecular Systems
510k clearance of diagnostic kits
- SpectraScience
Approval of the WavSTAT and WavSTAT II laser-induced fluorescence
devices for diagnosis of cancer
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