
Axis Biochemicals, Asa
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MODIFICATION TO IMX HOMOCYSTEINE is an FDA 510(k)-cleared medical device (K992274) manufactured by Axis Biochemicals, Asa. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 5, 1999. Regulation: 8.