ERYTHROPOIETIN IMMUNOASSAY KIT

ERYTHROPOIETIN IMMUNOASSAY KIT is an FDA 510(k)-cleared medical device (K952559) manufactured by Nichols Institute. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 28, 1996. Regulation: 8.