
Stanbio Laboratory
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STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET is an FDA 510(k)-cleared medical device (K941313) manufactured by Stanbio Laboratory. 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 16, 1994. Regulation: 8.