
Primus, Inc.
Free shipping on orders over $99 · 30-day returns
DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM) is an FDA 510(k)-cleared medical device (K896582) manufactured by Primus, Inc.. 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 27, 1990. Regulation: 8.