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Centocor tumor marker reclassification petition to be approved "shortly" via FDA letter.

This article was originally published in The Gray Sheet

Executive Summary

SERUM TUMOR MARKER MOVE TO CLASS II WILL BE OUTLINED IN LETTER TO CENTOCOR which FDA plans to send "shortly," agency staffers say. Upon issuance of the letter, serum tumor markers will be considered Class II products and will go to market via 510(k), FDA says. A subsequent order in the Federal Register will formalize FDA's decision to downclassify serum tumor markets.

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