ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12

ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12 is an FDA 510(k)-cleared medical device (K023222) manufactured by Invitrocare, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 25, 2002. Regulation: 8.