ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION

ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION is an FDA 510(k)-cleared medical device (K991341) manufactured by Irvine Scientific Sales Co., 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 July 7, 1999. Regulation: 8.