
Helena Laboratories
Free shipping on orders over $99 · 30-day returns
CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V) is an FDA 510(k)-cleared medical device (K921465) manufactured by Helena Laboratories. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 28, 1992. Regulation: 8.