
Colony Laboratories, Inc.
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FPR THEOPHYLLINE CALIBRATOR KIT is an FDA 510(k)-cleared medical device (K894530) manufactured by Colony Laboratories, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 17, 1989. Regulation: 8.