
Boehringer Mannheim Corp.
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COAGUCHEK PST SYSTEM is an FDA 510(k)-cleared medical device (K962571) manufactured by Boehringer Mannheim Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 21, 1997. Regulation: 8.