
Behring Diagnostics, Inc.
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PROC APC ASSAY, PROC CONTROL PLASMA is an FDA 510(k)-cleared medical device (K962968) manufactured by Behring Diagnostics, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 1996. Regulation: 8.