
Catch Incorporated
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LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT is an FDA 510(k)-cleared medical device (K062808) manufactured by Catch Incorporated. 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 12, 2006. Regulation: 8.