URINE REAGENT STRIP-3 PARAMETERS

URINE REAGENT STRIP-3 PARAMETERS is an FDA 510(k)-cleared medical device (K940469) 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 September 8, 1994. Regulation: 8.