LEECO E2 QUANT DIAG. TEST KIT

LEECO E2 QUANT DIAG. TEST KIT is an FDA 510(k)-cleared medical device (K834586) manufactured by Leeco Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 8, 1984. Regulation: 8.