CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER

CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER is an FDA 510(k)-cleared medical device (K993375) manufactured by Clinical Diagnostic Solutions, 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 19, 1999. Regulation: 8.