
Eastman Kodak Company
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KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION is an FDA 510(k)-cleared medical device (K915701) 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 January 26, 1992. Regulation: 8.