
Biotope, Inc.
Free shipping on orders over $99 · 30-day returns
ECLIPSE ICA BUN is an FDA 510(k)-cleared medical device (K905602) manufactured by Biotope, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 15, 1991. Regulation: 8.