COAT-A-COUNT GENTAMICIN RIA KIT

COAT-A-COUNT GENTAMICIN RIA KIT is an FDA 510(k)-cleared medical device (K811844) manufactured by Diagnostic Products 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 July 9, 1981. Regulation: 8.