510(k) K991480

EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP by Selfcare, Inc. — Product Code CGA

K991480 is an FDA 510(k) premarket notification submitted by Selfcare, Inc. for the device "EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP". The FDA issued a decision of Substantially Equivalent on September 17, 1999. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Selfcare, Inc. has at least 10 other 510(k) clearances on record.