KODAK SURECELL(TM) HCG-URINE KIT

KODAK SURECELL(TM) HCG-URINE KIT is an FDA 510(k)-cleared medical device (K874388) manufactured by Eastman Kodak Company. 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 7, 1988. Regulation: 8.