ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO

ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO is an FDA 510(k)-cleared medical device (K832947) manufactured by Ortho Diagnostic Systems, Inc.. This device is classified under the Hematology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 28, 1983. Regulation: 8.