SANDARE ACID PHOSPHATASE PROCEDURE

SANDARE ACID PHOSPHATASE PROCEDURE is an FDA 510(k)-cleared medical device (K842516) manufactured by Sandare Chemical Co., Inc.. 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 August 16, 1984. Regulation: 8.