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ChemTrak to submit 510(k) for H. pylori physician test by year-end.

This article was originally published in The Gray Sheet

Executive Summary

CHEMTRAK 510(K) FOR H. PYLORI PHYSICIAN-OFFICE TEST will be sent to FDA by year-end, according to the company. ChemTrak says the 510(k) for the physician-use test will be submitted upon completion of multicenter clinical trials involving "a few hundred patients." The "one-step" whole blood test can indicate the presence or absence of H. pylori antibodies "in minutes," ChemTrak says. The company plans to submit a 510(k) for a home-use version of the technology in 1996.

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