CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY

CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY is an FDA 510(k)-cleared medical device (K901298) manufactured by Olympus Corp.. 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 April 24, 1990. Regulation: 8.