REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA)

REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA) is an FDA 510(k)-cleared medical device (K925385) manufactured by Alko Diagnostic Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 12, 1994. Regulation: 8.