
Siemens Medical Solutions Diagnostics
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IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) is an FDA 510(k)-cleared medical device (K071017) manufactured by Siemens Medical Solutions Diagnostics. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 1, 2007. Regulation: 8.