
Ciba Corning Diagnostics Corp.
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ACS GENTAMICIN is an FDA 510(k)-cleared medical device (K953020) manufactured by Ciba Corning Diagnostics Corp.. 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 August 1, 1995. Regulation: 8.