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This article was originally published in The Gray Sheet

Executive Summary

Plans to submit a 510(k) for its EPOC 2000 blood-chemistry analyzer during the third quarter of 1993. The EPOC 2000 is a point-of-care diagnostic instrument that can perform multiple blood tests in under 10 minutes ("The Gray Sheet" Dec. 23, 1991, p. 5). The 510(k) filing will cover five tests, and the firm says that a second filing for a "full complement of tests" will take place following FDA clearance of the original 510(k). Abaxis recently revised the rotor of the EPOC 2000 to correct deficiencies seen with a prototype version of the device. The redesigned device can separate the patient's whole blood and measure the plasma sample with "the desired level of accuracy," the firm says.



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