
Clinical Micro Sensors
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ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 is an FDA 510(k)-cleared medical device (K051435) manufactured by Clinical Micro Sensors. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 18, 2006. Regulation: 8.