REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION

REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION is an FDA 510(k)-cleared medical device (K911954) manufactured by Bio-Rad. 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 May 22, 1991. Regulation: 8.