
Olympus America, Inc.
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OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT is an FDA 510(k)-cleared medical device (K954537) manufactured by Olympus America, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 13, 1996. Regulation: 8.