HAPTOGLOBIN NEPHELOMETRIC ASSAY

HAPTOGLOBIN NEPHELOMETRIC ASSAY is an FDA 510(k)-cleared medical device (K801433) manufactured by J.T. Baker Chemical Co.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 7, 1980. Regulation: 8.