510(k) K982089

ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS by Boehringer Mannheim Corp. — Product Code LFR

K982089 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS". The FDA issued a decision of Substantially Equivalent on September 3, 1998. The device falls under product code LFR (Glucose Dehydrogenase, Glucose), a Class II device regulated under 21 CFR 862.1345. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.