KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION

KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION is an FDA 510(k)-cleared medical device (K936138) 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 April 7, 1994. Regulation: 8.