QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)

QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) is an FDA 510(k)-cleared medical device (K023335) manufactured by Qc Sciences, LLC. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 17, 2003. Regulation: 8.