
Eastman Kodak Company
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KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA is an FDA 510(k)-cleared medical device (K922736) 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 July 9, 1992. Regulation: 8.