
Siemens Healthcare Diagnostics, Inc.
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Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) is an FDA 510(k)-cleared medical device (K222439) manufactured by Siemens Healthcare Diagnostics, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 7, 2023. Regulation: 8.