510(k) K871835

GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT by Miles Laboratories, Inc. — Product Code CGA

K871835 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT". The FDA issued a decision of Substantially Equivalent on December 22, 1987. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.