ACCU-CHEK COMFORT CURVE TEST STRIP

ACCU-CHEK COMFORT CURVE TEST STRIP is an FDA 510(k)-cleared medical device (K982002) manufactured by Boehringer Mannheim Corp.. 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 September 1, 1998. Regulation: 8.