
Biochem Immunosystems (U.S.), Inc.
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SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX is an FDA 510(k)-cleared medical device (K960072) manufactured by Biochem Immunosystems (U.S.), 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 March 5, 1997. Regulation: 8.