FRESHFROZEN CELLS, HEP-2

FRESHFROZEN CELLS, HEP-2 is an FDA 510(k)-cleared medical device (K962782) manufactured by Diagnostic Hybrids, Inc.. This device is classified under the Hematology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 28, 1996. Regulation: 8.