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Teco Diagnostics
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AMYLASE LIQUID REAGENT, MODEL A532-200 is an FDA 510(k)-cleared medical device (K040920) manufactured by Teco Diagnostics. 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 May 9, 2004. Regulation: 8.