DIASTIX REAGENT STRIPS FOR URINALYSIS

DIASTIX REAGENT STRIPS FOR URINALYSIS is an FDA 510(k)-cleared medical device (K831600) 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 September 7, 1983. Regulation: 8.