
Elan Holdings, Inc.
Free shipping on orders over $99 · 30-day returns
HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT is an FDA 510(k)-cleared medical device (K992845) manufactured by Elan Holdings, 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 October 17, 1999. Regulation: 8.