PROFILE CARDIAC SET ASSAYED SERUM CONTR.

PROFILE CARDIAC SET ASSAYED SERUM CONTR. is an FDA 510(k)-cleared medical device (K803036) manufactured by General Diagnostics. This device is classified under the Clinical Toxicology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 21, 1980. Regulation: 8.