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In Brief: Immucor

This article was originally published in The Gray Sheet

Executive Summary

Immucor: Responds to FDA's questions on a 510(k) submission for its ABS2000 automated analyzer for blood banks, the Norcross, Georgia-based firm says Sept. 22. FDA's questions addressed "the instrument, software, and the company's reagent products used to run" the ABS2000, which Immucor developed to automate "certain labor intensive, time consuming blood transfusion compatibility tests currently performed manually by laboratory technologists." Immucor submitted a 510(k) for the device on March 18, 1996 ("The Gray Sheet" March 25, 1996, In Brief)...

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