Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA

Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is an FDA 510(k)-cleared medical device (K190397) manufactured by Immunalysis Corporation. 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 November 14, 2019. Regulation: 8.