HTF WITH ALBUMIN (CATALOG NO. 9994)

HTF WITH ALBUMIN (CATALOG NO. 9994) is an FDA 510(k)-cleared medical device (K894405) manufactured by Irvine Scientific. 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 September 21, 1989. Regulation: 8.