
Siemens Healthcare Diagnostics, Inc.
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Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) is an FDA 510(k)-cleared medical device (K233242) manufactured by Siemens Healthcare Diagnostics, 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 January 17, 2024. Regulation: 8.