MARDX MITOCHONDRIA EIA TEST SYSTEM

MARDX MITOCHONDRIA EIA TEST SYSTEM is an FDA 510(k)-cleared medical device (K950110) manufactured by Hogan & Hartson. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 14, 1995. Regulation: 8.