
Miles Laboratories, Inc.
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SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. is an FDA 510(k)-cleared medical device (K864530) manufactured by Miles Laboratories, 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 February 17, 1987. Regulation: 8.