N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET

N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET is an FDA 510(k)-cleared medical device (K964418) manufactured by Kamiya Technology Services. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 1996. Regulation: 8.