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FDA clears first "special" 510(k)

This article was originally published in The Gray Sheet

Executive Summary

Casco Standards receives clearance April 24 for its lactate ammonia ethanol calibrator, agency staffers say. Under the special 510(k) program, companies can submit certification of compliance with quality systems requirements in lieu of data for a device modification. FDA's okay comes 10 days after the firm submitted to the Division of Clinical Laboratory Devices in the agency's Office of Device Evaluation a premarket notification covering a device modification. At least four of the six divisions of ODE have received a special 510(k) under the program, which was finalized in March ("The Gray Sheet" March 23, p. 14)



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