PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560

PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 is an FDA 510(k)-cleared medical device (K010750) manufactured by Fisher Diagnostics. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 6, 2001. Regulation: 8.