ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS

ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS is an FDA 510(k)-cleared medical device (K952875) 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 November 20, 1995. Regulation: 8.