PRODUCT #K3002 KETOTROL-N(URINE CONTROL)

PRODUCT #K3002 KETOTROL-N(URINE CONTROL) is an FDA 510(k)-cleared medical device (K760863) manufactured by Sigma Chemical Co.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 1, 1976. Regulation: 8.